FDA 510(k) Application Details - K142363

Device Classification Name	More FDA Info for this Device
510(K) Number	K142363
Device Name	NUSTAT, NUSTAT XR
Applicant	Beeken Biomedical 127 West Hargett Street, Suite 300 Raleigh, NC 27601 US Other 510(k) Applications for this Company
Contact	Richard Kendall Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/2014
Decision Date	01/09/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review