FDA 510(k) Application Details - K101580

Device Classification Name	Indicator, Physical/Chemical Sterilization Process   More FDA Info for this Device
510(K) Number	K101580
Device Name	Indicator, Physical/Chemical Sterilization Process
Applicant	NEV'S INK, INC 2500 W. SUNSET DR WAUKESHA, WI 53189-6326 US Other 510(k) Applications for this Company
Contact	DAVE MAROSE Other 510(k) Applications for this Contact
Regulation Number	880.2800   More FDA Info for this Regulation Number
Classification Product Code	JOJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/07/2010
Decision Date	07/01/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review