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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameCLARIS(R) CLEANING AND SOAKING SOLUTION
Classification Nameaccessories, soft lens products
Generic Namecleaning, disinfecting, and storage solution.
Regulation Number886.5928
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP870023
Supplement NumberS007
Date Received03/01/1996
Decision Date07/12/1996
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Alternate manufacturing site:allergan optical, 8301 mars drive, waco, texas 76712. The device, as modified, will be marketed under the trade name claris cleaning and soaking solution.
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