FDA 510(k) Application Details - K012569

Device Classification Name	Methyl Methacrylate For Cranioplasty   More FDA Info for this Device
510(K) Number	K012569
Device Name	Methyl Methacrylate For Cranioplasty
Applicant	BIOMET, INC. 56 EAST BELL DR. WARSAW, IN 46581-0587 US Other 510(k) Applications for this Company
Contact	SARA B SHULTZ Other 510(k) Applications for this Contact
Regulation Number	882.5300   More FDA Info for this Regulation Number
Classification Product Code	GXP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/09/2001
Decision Date	12/21/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review