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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 NameHYDRON HYDROPHILIC CONTACT LENS
Classification Namelenses, soft contact, daily wear
Generic Namelenses, soft contact, daily wear
Regulation Number886.5925
ApplicantCOOPERVISION, INC.
PMA NumberP780007
Supplement NumberS028
Date Received01/21/1988
Decision Date03/18/1988
Product Code
LPL[ Registered Establishments with LPL ]
Docket Number 88M-0129
Notice Date 06/08/1988
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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