FDA 510(k) Application Details - K023747

Device Classification Name Set, I.V. Fluid Transfer

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510(K) Number K023747
Device Name Set, I.V. Fluid Transfer
Applicant CARMEL PHARMA AB.
BOX 5352
GOTHENBURG 40228 SE
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Contact KJELL ANDREASSON
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Regulation Number 880.5440

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Classification Product Code LHI
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Date Received 11/08/2002
Decision Date 11/15/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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