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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 SALINE SOL.PH CHANGE
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantOptopics Laboratories Corp.
32 Main St., P.O. Box 210
Fairton, NJ 08320
PMA NumberP870007
Supplement NumberS010
Date Received10/03/1995
Decision Date04/22/1996
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 TRANSFER OF THE PROCESSING SITE FOR 100 PERCENT ETHYLENE OXIDE (ETO) STERILIZATION OF PLASTIC CONTAINERS, TIPS AND CLOSURES USED IN THE MANUFACTURE OF SORBIC ACID PRESERVED STERILE SALINE FOR SOFT CONTACT LENSES. THE ETO STERILIZATION FACILITY IS GRIFFITH MICROSCIENCE GLEN FALLS FACILITY, LOCATED IN GLEN FALLS, NY
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