FDA 510(k) Application Details - K001293

Device Classification Name Set, I.V. Fluid Transfer

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510(K) Number K001293
Device Name Set, I.V. Fluid Transfer
Applicant MEDIMOP MEDICAL PROJECTS, LTD.
815 CONNECTION AVENUE, N.W.
WASHINGTON, DC 20006-4004 US
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Contact BRUCE F MACKLER
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Regulation Number 880.5440

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Classification Product Code LHI
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Date Received 04/24/2000
Decision Date 05/05/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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