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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 K160654
Device Name GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)
Applicant
Covidien LLC
60 MIDDLETOWN AVE
north haven,  CT  06473
Applicant Contact rebecca magnanimo
Correspondent
Covidien LLC
60 MIDDLETOWN AVE
north haven,  CT  06473
Correspondent Contact rebecca magnanimo
Regulation Number876.5980
Classification Product Code
KNT  
Date Received03/08/2016
Decision Date 05/04/2016
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
Recalls CDRH Recalls
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