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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 | S038 |
Date Received | 08/13/2019 |
Decision Date | 09/10/2019 |
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 Introduction of a new flow cytometry analyzer to be used in replacement of the current cytometry analyzer at the CooperVision Caribbean Corporation facility in Juana Diaz, Puerto Rico. |