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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 NumberS004
Date Received06/08/1995
Decision Date02/23/1996
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 steri-tech, inc. , p. O. Box 1145, salinas, puerto rico 00751 as an alternate contract sterilization site, and for the use of 100% ethylene oxide to sterilize plastic bottles, tips, and caps used in the manufacture of the device.