FDA 510(k) Application Details - K981054

Device Classification Name	Indicator, Physical/Chemical Sterilization Process   More FDA Info for this Device
510(K) Number	K981054
Device Name	Indicator, Physical/Chemical Sterilization Process
Applicant	ALBERT BROWNE LTD. 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	CYNTHIA J M NOLTE, PH.D 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	03/23/1998
Decision Date	12/07/1998
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