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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 K121194
Device Name ENDO CLIP III 5MM CLIP APPLIER
Applicant
COVIDIEN
60 MIDDLETOWN AVE.
NORTH HAVEN,  CT  06473
Applicant Contact ANGELA VAN ARSDALE
Correspondent
COVIDIEN
60 MIDDLETOWN AVE.
NORTH HAVEN,  CT  06473
Correspondent Contact ANGELA VAN ARSDALE
Regulation Number878.4300
Classification Product Code
FZP  
Subsequent Product Code
GDO  
Date Received04/19/2012
Decision Date 05/03/2012
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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