Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: TRI POL 43 CONTACT LENS
• Generic Name: Lenses, soft contact, daily wear
• Regulation Number: 886.5925
• Applicant: Applied Optics, Inc.; 4218 Howard Ave.; Kensington, MD 20895
• PMA Number: N17951
• Supplement Number: S002
• Date Received: 12/26/1978
• Decision Date: 02/26/1979
• Product Code: LPL
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No