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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 WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID 84392
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantAlcon Laboratories
R
Van Nuys, CA 30348
PMA NumberP830071
Supplement NumberS006
Date Received12/04/1995
Decision Date06/04/1996
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 FOR AN ALTERNATE FORMULATION. THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME ALCON WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID 84392
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