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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Classification Nameaccessories, soft lens products
Generic Namecontact lense solution
Regulation Number886.5928
PMA NumberP910074
Supplement NumberS001
Date Received04/18/1997
Decision Date07/03/1997
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 expanding the indications to include use with silicone/acrylate and fluorosilicone/acrylate rigid gas permeable (rgp) contact lenses. When used with rgp lenses, the device will be marketed under the trade name, contaclair(r) rgp multi-purpose solution, and is indicated for use in cleaning, rinsing, disinfecting and storing daily and extended wear rgp contact lenses.