FDA Registration
Active
🇺🇸 United States
Boston Keratoprosthesis
Reg #: 3010798453
·
FEI: 3010798453
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- J.G. MACHINE CO.
- Registration Number
- 3010798453
- FEI Number
- 3010798453
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 21B Concord St.
- City
- Wilmington
- State
- MA
- ZIP
- 01887
- Country
- US
Regulatory Submissions
- 510(k) Number
- K915062
Owner / Operator
- Firm Name
- J.G. Machine Co.
- Operator Number
- 10056702
- Address
- 21B Concord St.
- City
- Wilmington
- State
- MA
- Postal Code
- 01887
- Country
- US
- Correspondent
- Susan Kinneen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Keratoprosthesis, Permanent Implant | HQM | Class 2 | Ophthalmic | No | 2018-01-08 |
Proprietary Names
Boston Keratoprosthesis
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)