FDA 510(k) Application Details - K150035

Device Classification Name	More FDA Info for this Device
510(K) Number	K150035
Device Name	V10 system
Applicant	VIORA LTD. 3 MASKIT STREET HERZLYIA 4673303 IL Other 510(k) Applications for this Company
Contact	OMRI KESLER Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/09/2015
Decision Date	05/01/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review