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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, nasogastric
510(k) Number K142483
Device Name TurboSEAL Nasogastric Aspiration Tube
Applicant
TurboSEAL, L.P.
7 Haarad St
Tel Aviv,  IL 6971060
Applicant Contact DORON BESSER
Correspondent
DOHMEN LIFE SCIENCE SERVICES, LLC
11925 W I-70 FRONTAGE ROAD NORTH, SUITE 900
WHEAT RIDGE,  CO  80033
Correspondent Contact IAN MARSDEN
Regulation Number876.5980
Classification Product Code
BSS  
Subsequent Product Code
FEG  
Date Received09/04/2014
Decision Date 12/19/2014
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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