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FDA 510(k) Application Details - K024080
Device Classification Name
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
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510(K) Number
K024080
Device Name
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Applicant
PERFUSION PARTNERS & ASSOC. INC.
P.O. BOX 4341
CROFTON, MD 21114 US
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Contact
E.J. Smith
Other 510(k) Applications for this Contact
Regulation Number
862.2050
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Classification Product Code
JQC
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More FDA Info for this Product Code
Date Received
12/10/2002
Decision Date
07/02/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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