KELMAN(TM) OMNIFIT II MODEL 2100
FDA premarket approval P850059/S001 · decided 1989-10-17
Approval details
- PMA number
- P850059
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- KELMAN(TM) OMNIFIT II MODEL 2100
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb Surgical, Inc.
- Date received
- 1987-02-20
- Decision date
- 1989-10-17
- Days to decision
- 970 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
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