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 NORMALINE KIT
• Generic Name: Accessories, soft lens products
• Regulation Number: 886.5928
• Applicant: Apothecary Products, Inc.; Burnsville Mn; Burnsville, MN 55337
• PMA Number: P800055
• Supplement Number: S002
• Date Received: 09/15/1982
• Decision Date: 05/27/1983
• Product Code: LPN
• Notice Date: 06/17/1983
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No