FDA 510(k) Application Details - K041691

Device Classification Name Set, I.V. Fluid Transfer

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510(K) Number K041691
Device Name Set, I.V. Fluid Transfer
Applicant WEST PHARMACEUTICAL SERVICES, INC.
101 GORDON DR.
LIONVILLE, PA 19341 US
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Contact DAVID WEISER
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Regulation Number 880.5440

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Classification Product Code LHI
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Date Received 06/22/2004
Decision Date 08/05/2004
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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