FDA 510(k) Application Details - K063159

Device Classification Name	Sterilant, Medical Devices   More FDA Info for this Device
510(K) Number	K063159
Device Name	Sterilant, Medical Devices
Applicant	PURICORE, INC. 320 KING OF PRUSSIA ROAD SUITE 200 RADNOR, PA 19087 US Other 510(k) Applications for this Company
Contact	HOWARD MANN Other 510(k) Applications for this Contact
Regulation Number	880.6885   More FDA Info for this Regulation Number
Classification Product Code	MED Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/17/2006
Decision Date	04/02/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review