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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 K061288
Device Name AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER
Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK,  CT  06856
Applicant Contact FRANK GIANELLI
Correspondent
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK,  CT  06856
Correspondent Contact FRANK GIANELLI
Regulation Number878.4300
Classification Product Code
FZP  
Date Received05/09/2006
Decision Date 11/02/2006
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
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