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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.
 
DeviceH55 HYDROPHILIC CONTACT LENS/OCUFILCON D 55% HYDRO. CONTACT LENSES FOR EXTENDED WEAR
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
Applicant
THE COOPER COMPANIES
6150 stoneridge mall road
suite 370
pleasanton, CA 94588
PMA NumberP890023
Supplement NumberS005
Date Received10/23/1995
Decision Date05/06/1997
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the cast molding method for the manufacture of the ocufilcon d 55% hydrophilic contact lens for extended wear at the company's facility located at sant isabel industrial park (formally known as felicia ward industrial park); highway 538, km 0. 7, puerto rico 00757.
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