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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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More FDA Info for this Product Code
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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