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Device | ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses |
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 | S035 |
Date Received | 08/09/2018 |
Decision Date | 03/08/2019 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for new packaging and labeling site to CooperVision Manufacturing, Ltd, Southampton, United Kingdom. |