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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Tissue Approximation Device
510(k) Number K082659
Device Name MODIFIED ENDO STICH
Applicant
Covidien Lp, Formerly Registered AS United States
60 Middletown Ave.
North Haven,  CT  06473
Applicant Contact ROBERT ZOTT
Correspondent
Covidien Lp, Formerly Registered AS United States
60 Middletown Ave.
North Haven,  CT  06473
Correspondent Contact ROBERT ZOTT
Regulation Number876.1500
Classification Product Code
OCW  
Date Received09/12/2008
Decision Date 09/19/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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