H55 HYDROPHILIC CONTACT LENS/OCUFILCON D 55% HYDRO. CONTACT LENSES
FDA premarket approval P890023/S003 · decided 1996-07-12
Approval details
- PMA number
- P890023
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- H55 HYDROPHILIC CONTACT LENS/OCUFILCON D 55% HYDRO. CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 1995-09-29
- Decision date
- 1996-07-12
- Days to decision
- 287 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR TINTING, WET PROCESSING, PACKAGING, AND STERILIZATION OF THE ABOVE-REFERENCED LENSES AT THE COMPANY'S FACILITY LOCATED AT SANTA ISABEL INDUSTRIAL PARK (FORMALLY KNOWN AS FELICIA WARD INDUSTRIAL PARK); HIGHWAY 538, KM 0.7, PUERTO RICO 00757
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