FDA 510(k) Application Details - K071934

Device Classification Name	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use   More FDA Info for this Device
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 Other 510(k) Applications for this Company
Contact	MARY L VERSTYNEN Other 510(k) Applications for this Contact
Regulation Number	862.2050   More FDA Info for this Regulation Number
Classification Product Code	JQC Other 510(k) Applications for this Device   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