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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.
 
DeviceSEREINE WETTING & SOAKING SOLU. (NEW PRESERVATIVE)
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantTrp Company
1575 Delucci Ln. #115
Reno, NV 89502
PMA NumberP870051
Supplement NumberS006
Date Received06/04/1996
Decision Date06/02/1997
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an expansion of the indications for use of the subject devices to include fluorosilicone acrylate rigid gas permeable contact lenses.
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