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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 NumberS009
Date Received08/08/1995
Decision Date09/20/1995
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFICATION OF THE STABILITY SPECIFICATIONS FOR SORBIC ACID CONCENTRATION FROM A RANGE OF 0.80 MG/ML - 1.20 MG/ML TO 0.70 MG/ML - 1.20 MG/ML
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