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FDA 510(k) Application Details - K071934
Device Classification Name
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
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510(K) Number
K071934
Device Name
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Applicant
BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
WARSAW, IN 46582 US
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Contact
MARY L VERSTYNEN
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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
07/13/2007
Decision Date
10/11/2007
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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