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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 K071406
Device Name AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER
Applicant
United States Surgical, A Division of Tyco Healthc
150 Glover Ave.
Norwalk,  CT  06856
Applicant Contact JENNIFER BRENNAN
Correspondent
United States Surgical, A Division of Tyco Healthc
150 Glover Ave.
Norwalk,  CT  06856
Correspondent Contact JENNIFER BRENNAN
Regulation Number878.4300
Classification Product Code
FZP  
Subsequent Product Code
GDO  
Date Received05/21/2007
Decision Date 11/21/2007
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
Predetermined Change
Control Plan Authorized		 No
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