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: THE SOFT RINSE SYSTEM
• Generic Name: Accessories, soft lens products
• Regulation Number: 886.5928
• Applicant: Dow Corning Corp. Healthcare Industries Materials; Stevens Pt., WI 54481
• PMA Number: P800060
• Supplement Number: S005
• Date Received: 09/22/1983
• Decision Date: 04/04/1984
• Product Code: LPN
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No