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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-ZYME ENZYMATIC CLEANER
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantAlcon Laboratories
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP820001
Supplement NumberS019
Date Received07/31/1996
Decision Date11/21/1996
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE USE OF OPTI-ONE(R) MULTI-PURPOSE SOLUTION AS A DILUENT FOR OPTI-ZYME(R) ENZYMATIC CLEANER TABLETS
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