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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 NameMODIFIED LABELING FOR IOL 60 MOS.STERILITY EXPIR.
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantEYETECH, LLC.
PMA NumberP880082
Supplement NumberS014
Date Received03/05/1992
Decision Date05/15/1992
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
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