H55 HYDROPHILIC CONTACT LENS/OCUFILCON D 55% HYDRO. CONTACT LENSES FOR EXTENDED WEAR
FDA premarket approval P890023/S006 · decided 1996-10-02
Approval details
- PMA number
- P890023
- Supplement
- S006
- 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 FOR EXTENDED WEAR
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 1996-02-13
- Decision date
- 1996-10-02
- Days to decision
- 232 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- ALTERNATE MANUFACTURING FACILITY AT RELIANT CLOSE, CHANDLERS FORD INDUSTRIAL ESTATE, CHANDLERS FORD, EASTLEIGH, HAMPSHIRE, S053 4ND, ENGLAND
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