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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameSEREINE WETTING & SOAKING SOLU. (NEW PRESERVATIVE)
Classification Nameaccessories, soft lens products
Generic Namewetting and soaking solution for rgp lenses
Regulation Number886.5928
ApplicantOPTIKEM INTERNATIONAL, INC.
PMA NumberP870051
Supplement NumberS006
Date Received06/04/1996
Decision Date06/02/1997
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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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