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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.
 
DeviceSORBIC ACID PRESERVED DAILY CLEANER
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantPaco Pharmaceutical Services, Inc.
1200 Paco Way
Bldg. 19
Lakewood, NJ 08701
PMA NumberP850076
Supplement NumberS009
Date Received05/01/1997
Decision Date07/02/1997
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR RELOCATION OF THE GRIFFITH MICROSCIENCE STERILIZATION SITE TO 27 PARK RD., GLEN FALLS, NY.
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