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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 Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
370 woodcliff drive
suite 200
fairport, NY 14450-0000
PMA NumberP780007
Supplement NumberS041
Date Received02/06/1996
Decision Date09/27/1996
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate manufacturing facility for the referenced device at reliant close, chandlers ford industrial estate, chandlers ford, eastleigh, hampshire, s053 4nd, england.