FDA 510(k) Application Details - K010703

Device Classification Name Set, I.V. Fluid Transfer

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510(K) Number K010703
Device Name Set, I.V. Fluid Transfer
Applicant DUOJECT MEDICAL SYSTEMS, INC.
50 RUE DE GASPE COMPLEX B-5
BROMONT, QC. J2L 2N8 CA
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Contact DANIEL MACDONALD
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Regulation Number 880.5440

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Classification Product Code LHI
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Date Received 03/09/2001
Decision Date 06/25/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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