FDA 510(k) Application Details - K150322

Device Classification Name	Cement, Bone, Vertebroplasty   More FDA Info for this Device
510(K) Number	K150322
Device Name	Cement, Bone, Vertebroplasty
Applicant	PAN MEDICAL LTD BARNETT WAY, BARNWOOD GLOUCESTER GL4 3RT GB Other 510(k) Applications for this Company
Contact	Jennie Budding 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	02/09/2015
Decision Date	03/06/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review