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. |
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Device | TC65B-SUV |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | EYEKON MEDICAL, INC. 2451 ENTERPRISE RD. CLEARWATER, FL 33763 |
PMA Number | P880072 |
Supplement Number | S045 |
Date Received | 12/11/1996 |
Decision Date | 03/13/1997 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 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 STERILIZATION SITE LOCATED AT TRI-STATE, HOSPITAL SUPPLY CORP., 3310 S. MAIN ST., SALISBURY, N.C. 28147 |
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