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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.
 
Trade NameH55 HYDROPHILIC CONTACT LENS/OCUFILCON D 55% HYDRO. CONTACT LENSES FOR EXTENDED WEAR
Classification Namelenses, soft contact, extended wear
Generic Namecontact lens
Regulation Number886.5925
ApplicantOCULAR SCIENCES PUERTO RICO, INC.
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 - other
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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