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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.
 
DeviceSINGLE PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
EYEKON MEDICAL, INC.
2451 enterprise rd.
clearwater, FL 33763
PMA NumberP880072
Supplement NumberS010
Date Received01/03/1990
Decision Date02/22/1990
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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