FDA 510(k) Application Details - K141254

Device Classification Name Stopcock, I.V. Set

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510(K) Number K141254
Device Name Stopcock, I.V. Set
Applicant ELCAM MEDICAL ACAL
KIBBUTZ BARAM
MP MEROM HAGALIL 1386000 IL
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Contact NATASHA BRANZBURG
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Regulation Number 880.5440

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Classification Product Code FMG
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Date Received 05/14/2014
Decision Date 07/30/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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