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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 K020470
Device Name MODIFICATION TO CORLINK AUTOMATED ANASTOMOTIC DEVICE
Applicant
Bypass , Ltd.
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Applicant Contact JONATHAN S KAHAN
Correspondent
Bypass , Ltd.
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Correspondent Contact JONATHAN S KAHAN
Regulation Number878.4300
Classification Product Code
FZP  
Date Received02/12/2002
Decision Date 03/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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