Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: AQUASEPT II
• Classification Name: lenses, soft contact, extended wear
• Regulation Number: 886.5925
• Applicant: COOPERVISION OPHTHALMIC PRODUCTS
• PMA Number: N17679
• Supplement Number: S001
• Date Received: 05/01/1979
• Decision Date: 08/09/1979
• Product Code: LPM [ Registered Establishments with LPM ]
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No