FDA 510(k) Application Details - DEN090012

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN090012
Device Name	VIRULITE COLD SORE MACHINE
Applicant	VIRULITE LLC 5405 ALTON PARKWAY, 5A SUITE 530 IRVINE, CA 92604 US Other 510(k) Applications for this Company
Contact	BEKY PINE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OKJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/30/2009
Decision Date	10/18/2012
Decision	DENG -
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review