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FDA 510(k) Application Details - K972159
Device Classification Name
Microfilter, Blood Transfusion
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510(K) Number
K972159
Device Name
Microfilter, Blood Transfusion
Applicant
BAXTER HEALTHCARE CORP.
ROUTE 120 AND WILSON RD.
ROUND LAKE, IL 60073 US
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Contact
MARY E SNYDER
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Regulation Number
880.5440
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Classification Product Code
CAK
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More FDA Info for this Product Code
Date Received
06/09/1997
Decision Date
07/23/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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