FDA 510(k) Application Details - K070666

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

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510(K) Number K070666
Device Name Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Applicant PERFUSION PARTNERS & ASSOC. INC.
1970 N. LESLIE RD., NO 220
PAHRUMP, NV 89060 US
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Contact NANCY LORD MD. ESQ
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Regulation Number 862.2050

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Classification Product Code JQC
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Date Received 03/12/2007
Decision Date 06/20/2007
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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