FDA 510(k) Application Details - K072511

Device Classification Name Set, I.V. Fluid Transfer

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510(K) Number K072511
Device Name Set, I.V. Fluid Transfer
Applicant MEDIMOP MEDICAL PROJECTS, LTD.
101 GORDON DRIVE
LIONVILLE, PA 19341 US
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Contact ARI Y SOBEL
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Regulation Number 880.5440

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Classification Product Code LHI
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Date Received 09/06/2007
Decision Date 12/13/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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