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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 NameDANKER SILICONE LENS (DIMEFOCON-A)
Classification Namelenses, soft contact, extended wear
Generic Namecontact lens for aphakic ext wear
Regulation Number886.5925
ApplicantBARNES-HIND, INC.
PMA NumberP790010
Supplement NumberS004
Date Received06/23/1983
Decision Date12/13/1984
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
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