FDA 510(k) Application Details - K962649

Device Classification Name	Indicator,Chemical,Enzymatic,Sterilization Process   More FDA Info for this Device
510(K) Number	K962649
Device Name	Indicator,Chemical,Enzymatic,Sterilization Process
Applicant	NORTH AMERICAN SCIENCE ASSOC., INC. 2261 TRACY RD. NORTHWOOD, OH 43619 US Other 510(k) Applications for this Company
Contact	MATTHEW SLIVA Other 510(k) Applications for this Contact
Regulation Number	880.2800   More FDA Info for this Regulation Number
Classification Product Code	MTC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/08/1996
Decision Date	09/26/1997
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	N
Expedited Review