FDA 510(k) Application Details - K171796

Device Classification Name Set, I.V. Fluid Transfer

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510(K) Number K171796
Device Name Set, I.V. Fluid Transfer
Applicant Medimop Medical Project Ltd.
17 Hatidhar St
Ra'anana 43665 IL
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Contact Jeffrey Ravel
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Regulation Number 880.5440

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Classification Product Code LHI
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Date Received 06/16/2017
Decision Date 10/12/2017
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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