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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.
 
DeviceBAUSCH & LOMB RENEW (R) SALINE SOLN. (BL-101-BEU13
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantBausch & Lomb, Inc.
14853 DEVEAU PLACE
MINNETONKA, MN 55345
PMA NumberP800024
Supplement NumberS017
Date Received02/07/1995
Decision Date05/05/1995
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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