FDA 510(k) Application Details - K142483

Device Classification Name Tube, Nasogastric

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510(K) Number K142483
Device Name Tube, Nasogastric
Applicant TurboSEAL, L.P.
7 Haarad St
Tel Aviv 6971060 IL
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Contact DORON BESSER
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Regulation Number 876.5980

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Classification Product Code BSS
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Date Received 09/04/2014
Decision Date 12/19/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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