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FDA 510(k) Application Details - K050805
Device Classification Name
Set, Blood Transfusion
More FDA Info for this Device
510(K) Number
K050805
Device Name
Set, Blood Transfusion
Applicant
BLOOD PRODUCTS SPECIALTIES LLC
184 SEIFFERT COURT
OCEANSIDE, NY 11572 US
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Contact
ALAN A WALDMAN
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
03/30/2005
Decision Date
06/20/2005
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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