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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 NameELASTIC LENS(TM) AA-4203 & CHIROFLEX(TM) 32-C10XX
Classification Nameintraocular lens
Generic Nameiol
Regulation Number886.3600
ApplicantSTARR SURGICAL CO.
PMA NumberP880091
Supplement NumberS004
Date Received12/18/1992
Decision Date08/30/1994
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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