FDA 510(k) Application Details - DEN130004

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN130004
Device Name	MOERAE SURGICAL MARKING PEN
Applicant	MOERAE MATRIX, INC. 675 US HIGHWAY 1 NORTH BRUNSWICK, NJ 08902 US Other 510(k) Applications for this Company
Contact	ROBERT J CHIN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/06/2013
Decision Date	12/18/2014
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