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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameOPTI-SOAK(TM) CONDITIONING SOLUTION 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 NumberS007
Date Received08/20/1996
Decision Date02/10/1997
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to reduce the minimum gamma radiation sterilization doese specification from 25. 0 kgy to 16. 2 kgy for the majority of primary packaging components (bottles, plugs and closures), and from 25. 0 kgy to 18. 0 kgy for the 8 oz. High density polyethylene (hdpe) bottles and the 15 oz. Low density polyethylene (ldpe) bottles.
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