FDA 510(k) Application Details - K000367

Device Classification Name Set, I.V. Fluid Transfer

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510(K) Number K000367
Device Name Set, I.V. Fluid Transfer
Applicant EUROSPITAL
15 OAK ST.
BEVERLY FARMS, MA 01915 US
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Contact FRAN WHITE
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Regulation Number 880.5440

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Classification Product Code LHI
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Date Received 02/04/2000
Decision Date 02/29/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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