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FDA 510(k) Application Details - K050115
Device Classification Name
Set, Blood Transfusion
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510(K) Number
K050115
Device Name
Set, Blood Transfusion
Applicant
CARDINAL HEALTH, ALARIS PRODUCTS
10221 WATERIDGE CIRCLE
SAN DIEGO, CA 92121-2772 US
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Contact
STACY L LEWIS
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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
01/18/2005
Decision Date
04/01/2005
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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