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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Trade NameSENSITIVE EYES(TM) SALINE & CLEANING SOLUTION
Classification Nameaccessories, soft lens products
Regulation Number886.5928
ApplicantBAUSCH & LOMB, INC.
PMA NumberP820031
Supplement NumberS014
Date Received10/10/1996
Decision Date03/10/1997
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for reducing the fill volume for renu(r) lens rewetting drops from the currently approved 5 ml to 3 ml in the same 7. 5 ml bottle.
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