FDA 510(k) Application Details - K190012

Device Classification Name	More FDA Info for this Device
510(K) Number	K190012
Device Name	OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid
Applicant	Medtrade Product Ltd Electra House, Electra way, Crewe Business Park Crewe CW1 6GL GB Other 510(k) Applications for this Company
Contact	Mina Patel 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	01/03/2019
Decision Date	12/18/2019
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