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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, double lumen for intestinal decompression and/or intubation
510(k) Number K053410
Device Name GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR
Applicant
KENDALL
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Applicant Contact JIM WELSH
Correspondent
KENDALL
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Correspondent Contact JIM WELSH
Regulation Number876.5980
Classification Product Code
FEG  
Date Received12/07/2005
Decision Date 01/06/2006
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
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