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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameALCON WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID 84392
Classification Nameaccessories, soft lens products
Generic Namewetting, soaking, and disisfec. solut.
Regulation Number886.5928
ApplicantALCON LABORATORIES
PMA NumberP830071
Supplement NumberS006
Date Received12/04/1995
Decision Date06/04/1996
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate formulation. The device as modified will be marketed under the trade name alcon wetting, soaking, conditioning, and disinfecting solution id 84392.
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