FDA 510(k) Application Details - K111593

Device Classification Name	Cement, Bone, Vertebroplasty   More FDA Info for this Device
510(K) Number	K111593
Device Name	Cement, Bone, Vertebroplasty
Applicant	BM KOREA CO., LTD. 1733 CANTON LANE MARIETTA, GA 30062-2670 US Other 510(k) Applications for this Company
Contact	RONALD D ARKIN 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	06/07/2011
Decision Date	11/18/2011
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