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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clip, implantable
510(k) Number K033979
Device Name CORLINK AUTOMATED ANASTOMOTIC SYSTEM
Applicant
BY-PASS MAKAFIM LTD.
555 13TH ST. NW
WASHINGTON,  DC  20004 -1109
Applicant Contact JONATHAN S KAHAN
Correspondent
BY-PASS MAKAFIM LTD.
555 13TH ST. NW
WASHINGTON,  DC  20004 -1109
Correspondent Contact JONATHAN S KAHAN
Regulation Number878.4300
Classification Product Code
FZP  
Date Received12/23/2003
Decision Date 03/31/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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