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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.
 
DevicePOSTERIOR CHAMBER INTRAOCULAR LENS
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
EYEKON MEDICAL, INC.
2451 enterprise rd.
clearwater, FL 33763
PMA NumberP880072
Supplement NumberS047
Date Received02/08/1999
Decision Date06/20/2000
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the manufacturing facility located at medical developmental research, inc. , clearwater, florida 33763.
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