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: HYDRACON(R) CONTACT LENSES
• Generic Name: Lenses, soft contact, daily wear
• Regulation Number: 886.5925
• Applicant: Hydracon; 718 Paseo Montecito; Newbury Park, CA 91320
• PMA Number: P820017
• Supplement Number: S005
• Date Received: 03/14/1983
• Decision Date: 04/28/1983
• Product Code: LPL
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No