FDA 510(k) Application Details - K093593

Device Classification Name	More FDA Info for this Device
510(K) Number	K093593
Device Name	CELOX PRO, CELOX PRO OTC, CELOX HEMOSTATIC GRANULES, CELOX PRO HEMOSTATIC GRANULES, OMNI STAT PRO
Applicant	MEDTRADE PRODUCTS LIMITED ELECTRA HOUSE CREW BUSINESS PARK CREWE, CHESHIRE CWI 6GL GB Other 510(k) Applications for this Company
Contact	JONATHAN RANFIELD 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	11/19/2009
Decision Date	01/20/2010
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