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FDA 510(k) Application Details - K042473
Device Classification Name
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
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510(K) Number
K042473
Device Name
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Applicant
COBE CARDIOVASCULAR, INC.
14401 WEST 65TH WAY
ARVADA, CO 80004-3599 US
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Contact
JACK ELLISON
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Regulation Number
862.2050
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Classification Product Code
JQC
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Date Received
09/13/2004
Decision Date
11/19/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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