FDA Registration
Active
🇺🇸 United States
Red & Green Trial Lenses
Reg #: 2518410
·
FEI: 2518410
·
Expires 2025
Products
1
Proprietary Names
14
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GULDEN OPHTHALMICS
- Registration Number
- 2518410
- FEI Number
- 2518410
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 225 CADWALADER AVE.
- City
- Elkins Park
- State
- PA
- ZIP
- 19027
- Country
- US
Owner / Operator
- Firm Name
- GULDEN OPHTHALMICS INC
- Operator Number
- 2518410
- Address
- 225 CADWALADER AVE., --
- City
- Elkins Park
- State
- PA
- Postal Code
- 19027
- Country
- US
- Correspondent
- SEAN T COCKLEY
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Spectacle Dissociation, Battery-Powered (Lancaster) | HLO | Class 1 | Ophthalmic | No | 1995-03-21 |
Proprietary Names
Red & Green Trial Lenses
Red & Green Pediatric Glasses (6pk)
LED Three Character Test
Reversed Red & Green Glasses Pediatric Frame #4
Reversed Red & Green Wrap-Around Glasses Adult
Red & Green Wrap-Around Glasses Child
Red & Green Glasses Pediatric Frame #3
Red & Green Black Frame Glasses (6pk)
Red & Green Glasses Adult Black Frame #1
LED Worth Four Dot Test
Red & Green Wrap-Around Glasses Adult
Reversed Red & Green Wrap-Around Glasses Child
Reversed Red & Green Adult Glasses Black Frame #2
Red & Green Spectacles
Establishment Types
Manufacture Medical Device