FDA 510(k) Application Details - K113560

Device Classification Name	More FDA Info for this Device
510(K) Number	K113560
Device Name	CELOX GAUZE PRO
Applicant	MEDTRADE PRODUCTS LTD. ELECTRA HOUSE CREWE BUSINESS PARK CREWE CHESHIRE CW1 6GL GB Other 510(k) Applications for this Company
Contact	CLAIRE RYAN 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	12/01/2011
Decision Date	08/01/2012
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