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 BLAIREX SYSTEM
• Generic Name: Accessories, soft lens products
• Regulation Number: 886.5928
• Applicant: Blairex Laboratories, Inc.; 4810 Tecumseh Ln.,; P.O. Box 15190; Evansville, IN 47716
• PMA Number: P800028
• Supplement Number: S011
• Date Received: 03/02/1984
• Decision Date: 05/11/1984
• Product Code: LPN
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No