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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 | S033 |
Date Received | 06/15/2018 |
Decision Date | 09/07/2018 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to request a minor modification to the lens edge form. |