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FDA 510(k) Application Details - K972843
Device Classification Name
Set, Blood Transfusion
More FDA Info for this Device
510(K) Number
K972843
Device Name
Set, Blood Transfusion
Applicant
GLOBE ENT., INC.
4930 CAMPBELL RD.
HOUSTON, TX 77041 US
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Contact
STEPHEN Y JAN
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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
08/01/1997
Decision Date
12/16/1997
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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