OTI-05 & LATHE-40 (POLYMACON) LATHE-CUT HYDROPHILI
FDA premarket approval P890031/S003 · decided 1991-04-25
Approval details
- PMA number
- P890031
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OTI-05 & LATHE-40 (POLYMACON) LATHE-CUT HYDROPHILI
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- Ocular Technologies, Inc.
- Date received
- 1990-03-14
- Decision date
- 1991-04-25
- Days to decision
- 407 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Raleigh, NC
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