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: ACCUSEPT DISINFECTING UNIT
• Generic Name: Lenses, soft contact, daily wear
• Regulation Number: 886.5925
• Applicant: Strieter Laboratories, Inc.; 222 Vandalia St.; Collinsville, IL 62234
• PMA Number: N17734
• Supplement Number: S005
• Date Received: 09/05/1985
• Decision Date: 03/17/1986
• Product Code: LPL
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No