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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.
 
DeviceOPTI-FREE(R) SUPRA-CLENS DAILY PROTEIN REMOVER
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantAlcon Laboratories
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP820001
Supplement NumberS018
Date Received06/12/1995
Decision Date12/28/1995
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 A PANCREATIN-BASED LIQUIED ENZYMATIC CLEANER - THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME:OPTI-FREE SUPRA-CLENS DAILY PROTEIN REMOVER
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