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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceACCUTECH SINGLE & THREE PIECE INTRAOCULAR LENSES
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantEYETECH, LLC.
7016 6TH ST. NORTH
OAKDALE, MN 55128
PMA NumberP880082
Supplement NumberS017
Date Received02/03/1994
Decision Date10/04/1994
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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