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FDA 510(k) Application Details - K041496
Device Classification Name
Set, Blood Transfusion
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
880.5440
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Classification Product Code
BRZ
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More FDA Info for this Product Code
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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