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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Classification Nameaccessories, solution, ultrasonic cleaners for lenses
Generic Namesoft (hydrophilic) contact lens solution
Regulation Number886.5928
PMA NumberP960024
Supplement NumberS001
Date Received04/15/1997
Decision Date07/03/1997
Product Code
LYL[ Registered Establishments with LYL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for addition of ciba vision's solocare(tm) brand multi-purpose solution to the labeling of the unizyme(tm) enzymatic cleaner as a diluent to be used sequentially with the unizyme(tm) enzyme.