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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.
 
DeviceTC65B-SUV
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantEyekon Medical, Inc.
2451 Enterprise Rd.
Clearwater, FL 33763
PMA NumberP880072
Supplement NumberS045
Date Received12/11/1996
Decision Date03/13/1997
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE STERILIZATION SITE LOCATED AT TRI-STATE, HOSPITAL SUPPLY CORP., 3310 S. MAIN ST., SALISBURY, N.C. 28147
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