FDA 510(k) Application Details - K972035

Device Classification Name	Indicator, Physical/Chemical Sterilization Process   More FDA Info for this Device
510(K) Number	K972035
Device Name	Indicator, Physical/Chemical Sterilization Process
Applicant	SERIM RESEARCH CORP. P.O. BOX 4002 ELKHART, IN 46514-0002 US Other 510(k) Applications for this Company
Contact	ROBERT C BOGUSLASKI 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	06/02/1997
Decision Date	08/29/1997
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