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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 K100242
Device Name AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER
Applicant
Surgical Devices, A Division of Tyco Healthcare
60 Middletown Ave.
North Haven,  CT  06473
Applicant Contact NISHITH DESAI
Correspondent
Surgical Devices, A Division of Tyco Healthcare
60 Middletown Ave.
North Haven,  CT  06473
Correspondent Contact NISHITH DESAI
Regulation Number878.4300
Classification Product Code
FZP  
Subsequent Product Code
GDO  
Date Received01/27/2010
Decision Date 02/17/2010
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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