FDA 510(k) Application Details - K041232

Device Classification Name Set, I.V. Fluid Transfer

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510(K) Number K041232
Device Name Set, I.V. Fluid Transfer
Applicant GETTIG PHARMACEUTICAL INSTRUMENT CO.
ONE STREAMSIDE PL. WEST
SPRING MILLS, PA 16875-0085 US
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Contact JAMES A BENZ
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Regulation Number 880.5440

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Classification Product Code LHI
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Date Received 05/10/2004
Decision Date 07/22/2004
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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