EPCON SOFT (POLYMACON) SPHERICAL AND TORIC LENSES
FDA premarket approval P880049/S001 · decided 1991-07-19
Approval details
- PMA number
- P880049
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EPCON SOFT (POLYMACON) SPHERICAL AND TORIC LENSES
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- Epcon Laboratories
- Date received
- 1991-01-30
- Decision date
- 1991-07-19
- Days to decision
- 170 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- El Paso, TX
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