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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 K984438
Device Name MODIFIED AUTO SUTURE*VCS** ANASTOMOTIC**CLIP CARTRIDGE
Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK,  CT  06856
Applicant Contact CHRISTOPHER A GRAHAM
Correspondent
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK,  CT  06856
Correspondent Contact CHRISTOPHER A GRAHAM
Regulation Number878.4300
Classification Product Code
FZP  
Date Received12/14/1998
Decision Date 01/07/1999
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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