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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 81573
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantAlcon Laboratories
R
Van Nuys, CA 30348
PMA NumberP830034
Supplement NumberS034
Date Received03/04/1997
Decision Date07/02/1997
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO ALLOW FOR THE USE OF ALCON MULTI-PURPOSE SOLUTION ID 81573 (OPTI-ONE MULTI-PURPOSE SOLUTION) AS AN ALTERNATE DILUENT FOR OPTI-FREE(R) SUPRACLENS(R) DAILY PROTEIN REMOVER.
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