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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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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