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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.
 
DeviceSTERIDYNE STERILE PRESERVED SALINE SOLUTION
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantOptopics Laboratories Corp.
32 Main St., P.O. Box 210
Fairton, NJ 08320
PMA NumberP870007
Supplement NumberS001
Date Received01/27/1988
Decision Date07/19/1988
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
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