FDA 510(k) Application Details - DEN150007

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN150007
Device Name	Magnetic Surgical System
Applicant	Levita Magnetics International Corp. 1730 S.Amphlett Blvd, Ste 220 San Mateo, CA 94402 US Other 510(k) Applications for this Company
Contact	Cindy Domecus Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/10/2015
Decision Date	06/13/2016
Decision	DENG -
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review