FDA 510(k) Application Details - K041496

Device Classification Name Set, Blood Transfusion

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510(K) Number K041496
Device Name Set, Blood Transfusion
Applicant PENTAFERTE S.P.A
7240 NW 63 TERRACE
PARKLAND, FL 33067 US
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Contact VICTOR PEREIRA
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Regulation Number 880.5440

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Classification Product Code BRZ
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Date Received 06/04/2004
Decision Date 06/30/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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