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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K143088
Device Name GastriSail Gastric Positioning System
Applicant
Covidien
60 Middletown Ave.
North Haven,  CT  06473
Applicant Contact Debbie Peacock
Correspondent
Covidien
60 Middletown Ave.
North Haven,  CT  06473
Correspondent Contact Debbie Peacock
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/28/2014
Decision Date 02/25/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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