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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameDANKER SILICONE LENS (DIMEFOCON-A)
Classification Namelens, contact (other material) - daily
Generic Namecontact lens for aphakic ext wear
Regulation Number886.5916
ApplicantCIBA VISION CORPORATION
PMA NumberP790010
Date Received03/13/1979
Decision Date05/28/1982
Withdrawal Date 05/12/2009
Product Code
HQD[ Registered Establishments with HQD ]
Notice Date 07/13/1982
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S004 S005 S006 S007 
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