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: MESO(CELLULOSE ACETATE BUTYRATE) HARD CONTACT LENS
• Generic Name: Lens, contact (other material) - daily
• Regulation Number: 886.5916
• Applicant: Danker Laboratories, Inc.; 2202 S. Priest Dr.; Temple, AZ 85282
• PMA Number: N17878
• Supplement Number: S001
• Date Received: 09/02/1980
• Decision Date: 02/24/1981
• Product Code: HQD
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No