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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Tubes With Enteral Specific Connectors
510(k) Number K150711
Device Name Salem Sump Dual Lumen Stomach Tube with Multi-functional Port
Applicant
Covidien
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact Jim Welsh
Correspondent
Covidien
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact Wei Zhao
Regulation Number876.5980
Classification Product Code
PIF  
Subsequent Product Code
FEG  
Date Received03/19/2015
Decision Date 10/08/2015
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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