FDA Registration
Active
🇺🇸 United States
LT-300
Reg #: 3010023733
·
FEI: 3010023733
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- LUTECH INDUSTRIES INC.
- Registration Number
- 3010023733
- FEI Number
- 3010023733
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 105 Remington Blvd Suite C
- City
- Ronkonkoma
- State
- NY
- ZIP
- 11779
- Country
- US
Regulatory Submissions
- 510(k) Number
- K143119
Owner / Operator
- Firm Name
- Lutech Industries Inc.
- Operator Number
- 10043231
- Address
- 105 Remington Blvd., Suite C
- City
- Ronkonkoma
- State
- NY
- Postal Code
- 11779
- Country
- US
- Correspondent
- Le Vachula
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Colposcope (And Colpomicroscope) | HEX | Class 2 | Obstetrics/Gynecology | No | 2015-01-19 |
Proprietary Names
LT-300
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device