FDA Registration
Active
🇯🇵 Japan
Lapel Microphone for 9500(9500MC)
Reg #: 3003782610
·
FEI: 3003782610
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- HOYA Corporation PENTAX Lifecare Division
- Registration Number
- 3003782610
- FEI Number
- 3003782610
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 30-2 Okada, Aza-Shimomiyano, Tsukidate
- City
- KURIHARA-SHI Miyagi
- Country
- JP
Owner / Operator
- Firm Name
- HOYA Corporation PENTAX Division
- Operator Number
- 8030235
- Address
- 3 Paragon Drive
- City
- Montvale
- State
- NJ
- Postal Code
- 07645
- Country
- US
- Correspondent
- Gurvinder Nanda
US Agent
- Business Name
- HOYA CORPORATION PENTAX DIVISION
- Contact Name
- Gurvinder Nanda
- Address
- 3 Paragon Drive
- City
- Montvale
- State
- NJ
- ZIP
- 07645
- Country
- US
- [email protected]
- Phone
- 201 5712318
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laryngostroboscope | EQL | Class 1 | Ear, Nose, Throat | No | 2007-06-29 |
Proprietary Names
Lapel Microphone for 9500(9500MC)
LARYNGEAL STROBE (9500)
VIDEO LARYNGOSTROBOSCOPE (VLS-1190STK)
VIDEO LARYNGOSTROBOSCOPE (VLS-1070STK)
RIGID ENDOSCOPE, STERRAD (9109)
VIDEO LARYNGOSTROBOSCOPE (VLS-1590STI)
CARRYING CASE (VE-B11)
Footswitch for 9500(9500FS)
Laryngeal Microphone for 9500(9500LX)
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device