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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 Namelens rewetting solution
Regulation Number886.5928
PMA NumberP900047
Supplement NumberS003
Date Received05/05/1995
Decision Date04/12/1996
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for isotron ireland, ltd. Located at sragh industrial estate, tullamore, co. Offaly, ireland, as an alternate contract sterilization site, and for theuse of 100% ethylene oxide to sterilize the plastic bottles, tips, and caps.