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: KESTREL NO. 695 HEATER
• Generic Name: Accessories, soft lens products
• Regulation Number: 886.5928
• Applicant: Atrion Medical Products, Inc.; 1426 Curt Francis Rd.; Arab, AL 35016
• PMA Number: P820087
• Supplement Number: S004
• Date Received: 04/16/1985
• Decision Date: 11/18/1985
• Product Code: LPN
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No