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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namelens,contact(rigid gas permeable)-extended wear
Generic Namelens,contact(rigid gas permeable)-extended wear
Regulation Number886.5916
11460 johns creek parkway
duluth, GA 30097
PMA NumberP890020
Supplement NumberS002
Date Received07/16/1990
Decision Date09/18/1990
Product Code
MWL[ Registered Establishments with MWL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No