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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.
 
DeviceMODIFIED J-LOOP POSTERIOR CHAMBER IOL
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
EYEKON MEDICAL, INC.
2451 enterprise rd.
clearwater, FL 33763
PMA NumberP880072
Supplement NumberS036
Date Received08/25/1995
Decision Date02/12/1996
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 AN ALTERNATE CONTRACT STERILIZER, MEDICAL MANUFACTURING CORP., AT 2205 EAST 33RD STREET, ERIE, PA 16510, AND CONVERSION FROM 12/88 ETHYLENE OXIDE (ETO)/FREON TO 100% ETO STERILIZATION
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