EYE SPHERE, CONFORMERS
FDA 510(k) clearance K972661 · decided 1997-10-03
Clearance details
- K-number
- K972661
- Device name
- EYE SPHERE, CONFORMERS
- Applicant
- Gulden Ophthalmics
- Decision
- Substantially Equivalent
- Date received
- 1997-07-16
- Decision date
- 1997-10-03
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- HPZ
- Device class
- 2
- Regulation number
- 886.3320
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Elkins Park, PA, US
- Third-party review
- No
- Expedited review
- No
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