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Device | BIOMEDICS 55 (OCUFILCON D) UV BLOCKER IMT SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | THE COOPER COMPANIES 6150 Stoneridge Mall Road Suite 370 Pleasanton, CA 94588 |
PMA Number | P890023 |
Supplement Number | S008 |
Date Received | 07/29/1999 |
Decision Date | 08/13/1999 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement The 30-Day Notice requested a UV blocker process change at Ocular Sciences' Santa Isabel facility. |