FDA 510(k) Application Details - K103064

Device Classification Name	Cement, Bone, Vertebroplasty   More FDA Info for this Device
510(K) Number	K103064
Device Name	Cement, Bone, Vertebroplasty
Applicant	CAREFUSION 1500 WAUKEGAN ROAD WAUKEGAN, IL 60085 US Other 510(k) Applications for this Company
Contact	JOY GREIDANUS Other 510(k) Applications for this Contact
Regulation Number	888.3027   More FDA Info for this Regulation Number
Classification Product Code	NDN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/18/2010
Decision Date	01/10/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review