FDA 510(k) Application Details - K021902

Device Classification Name Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

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510(K) Number K021902
Device Name Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Applicant MEDTRONIC VASCULAR
7611 NORTHLAND DR.
MINNEAPOLIS, MN 55428 US
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Contact LUCY TAN
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Regulation Number 862.2050

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Classification Product Code JQC
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Date Received 06/10/2002
Decision Date 08/12/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee HE - Hematology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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