FDA 510(k) Application Details - K120652

Device Classification Name	Indicator, Physical/Chemical Sterilization Process   More FDA Info for this Device
510(K) Number	K120652
Device Name	Indicator, Physical/Chemical Sterilization Process
Applicant	SERIM RESEARCH CORP. 3506 Reedy Dr ELKHART, IN 46514 US Other 510(k) Applications for this Company
Contact	PATRICIA RUPCHOCK 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	03/02/2012
Decision Date	10/12/2012
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