FDA 510(k) Application Details - K021927

Device Classification Name	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use   More FDA Info for this Device
510(K) Number	K021927
Device Name	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Applicant	BIOMET, INC. 56 EAST BELL DR. WARSAW, IN 46581-0587 US Other 510(k) Applications for this Company
Contact	LONNIE WITHAM Other 510(k) Applications for this Contact
Regulation Number	862.2050   More FDA Info for this Regulation Number
Classification Product Code	LXG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/12/2002
Decision Date	07/12/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review