FDA Registration
Active
🇰🇷 South Korea
PB30-0150
Reg #: 3008285983
·
FEI: 3008285983
·
Expires 2025
Products
1
Proprietary Names
296
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- L&K BIOMED CO.,LTD.
- Registration Number
- 3008285983
- FEI Number
- 3008285983
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- #101, 201, #202, 16-25, Dongbaekjungang-ro 16 beon-gil, Giheung-gu
- City
- Yongin-SI Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K243357
Owner / Operator
- Firm Name
- L&K BIOMED CO., LTD.
- Operator Number
- 10033804
- Address
- #101, 201, 202, 16-25, Dongbaekjungang-ro,, 16 beon-gil, Giheung-gu
- City
- Youngin-si
- State
- Gyeonggi
- Postal Code
- 17015
- Country
- KR
- Correspondent
- Kihyang Kim
US Agent
- Business Name
- ComplianceAcuity, Inc
- Contact Name
- Kevin Randall
- Address
- 485 Clinton St, #888
- City
- Ridgeway
- State
- CO
- ZIP
- 81432
- Country
- US
- [email protected]
- Phone
- 303 8280844
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2025-03-06 |
Proprietary Names
PB30-0150
PB30-3145
PB30-0130
PB30-3100
PB28-3150
PB10-1011
PB30-0160
PB10-0014
PB28-0145
PB30-0060
PB28-0100
PB12-1019
PB30-2100
PB30-0080
PB12-1016
PFB12-2322
PB10-0016
PB25-E170
PB28-0150
PB28-1060
PB30-1115
PB30-0105
PB30-1080
PB12-1013
PB28-3165
PB10-0017
PB28-3130
PFB12-2012
PB30-3095
PB30-3085
PB28-1130
PB10-1007
PB10-0015
PB25-E130
PF12-2015
PB10-0018
CastleLoc Pectus Bar System
PB25-E150
PB28-1100
PB28-2060
PFB12-2315
PB28-0105
PB28-3155
PB28-2145
PB25-E065
PF12-2012
PB28-3105
PB28-1135
PB12-0014
PB10-1013
PB28-1160
PB28-1080
PB28-0080
PB12-1017
PB30-1095
PB28-2135
PB10-1015
PB10-0013
PFB12-2018
PB10-1019
PB28-0160
PB10-0019
PB30-0090
PB12-1008
PB30-1155
PB30-3075
PB12-0019
PB25-E145
PB30-2150
PB12-0016
PB30-2140
PB28-0165
PB30-1075
PB28-1085
PB10-1018
PB30-2065
PB28-3090
PB28-1140
PB28-3110
PB30-2130
PB10-1014
PF12-2322
PB30-2080
PB30-0135
PB12-0015
PB30-3070
PB30-0115
PB10-1012
PB28-3135
PB28-2075
PB30-2110
PB30-0125
PB28-3145
PB30-1125
PB28-2125
PB28-0075
PB28-0170
PB30-3115
PB28-0120
PF12-3018
PFB12-2818
PB30-3135
PB10-1008
PB30-2090
PB30-0145
PB28-3170
PB30-3160
PF12-2818
PB28-3080
PB12-0020
PFB12-2518
PB28-2140
PB28-0090
PB30-2145
PB28-1115
PB30-0165
PB30-2125
PB28-1090
PB12-0010
PB28-0130
PF12-2018
PB30-1070
PB30-3105
PB25-E105
PB12-0012
PB30-3060
PB30-3165
PB30-2155
PB10-0009
PB28-0110
PB30-3065
PB28-0095
PB28-2095
PB10-1009
PB30-0070
PB28-3140
PB28-1120
PB28-3085
PB28-1110
PB28-3160
PB30-1165
PB28-2070
PB10-0011
PF12-2315
PB25-E115
PB28-1070
PB28-2120
PB28-2160
PB30-0170
PF12-2815
PB30-0155
PB30-2075
PB28-2155
PB30-3120
PB28-2105
PB30-1135
PB28-3115
PB28-1105
PB28-1095
PB28-0140
PB30-0110
PB28-0065
PB28-1150
PB28-0060
PB30-0140
PB30-1085
PB30-0120
PB30-1090
PB12-1011
PB28-2100
PB30-2105
PB25-E090
PB28-3075
PB30-2135
PFB12-2815
PFB12-2822
PB25-E070
PB30-3130
PB10-0007
PB30-3155
PFB12-2312
PB30-1060
PB28-1145
PB28-0085
PB10-1016
PB12-0003
PB30-1110
PB30-1150
PB12-1007
PB28-3065
PB30-1130
PB25-E165
PB28-2165
PB25-E060
PB25-E075
PF12-2312
PB12-0008
PF12-2022
PB30-0085
PB12-1020
PB30-1120
PB28-1165
PB28-2090
PB28-2170
PB25-E160
PB12-0018
PB12-0007
PB25-E110
PB30-3125
PB30-1065
PB25-E100
PB28-1155
PB12-1018
PB28-1065
PB28-2110
PB28-2150
PB30-1170
PB25-E085
PB12-1012
PB30-1105
PFB12-3018
PFB12-2022
PB30-1140
PB25-E135
PB28-3070
PB25-E125
PN03-0007
PB12-0011
PB30-1145
PB30-3080
PB12-0009
PB30-3110
PB30-3150
PB12-0013
PB12-1015
PB10-0003
PB30-3090
PB10-1020
PB10-1017
PB28-0135
PB12-0017
PB25-E120
PFB12-2318
PF12-2318
PB12-1009
PB30-2170
PB30-3170
PB25-E155
PB10-0008
PB30-1100
PB25-E080
PB12-1014
PB30-3140
PB28-0155
PB25-E140
PB28-2115
PB30-2070
PB25-E095
PB10-0010
PB28-3095
PB28-0115
PB10-0020
PB28-3060
PB30-2160
PB28-1075
PB30-2060
PB10-1010
PB12-1010
PB28-2085
PFB12-2812
PB30-1160
PB28-2130
PFB12-2015
PC05-0175
PB30-2095
PB28-3120
PB30-2085
PF12-2822
PF12-2518
PB28-1125
PB28-3125
PB30-0100
PB28-2080
PB28-0070
PB30-2165
PB30-0065
PB30-2115
PB28-3100
PB30-2120
PB30-0095
PB28-2065
PB30-0075
PB28-0125
PB10-0012
PB28-1170
PF12-2812
Establishment Types
Manufacture Medical Device