FDA 510(k) Application Details - K002937

Device Classification Name	Indicator, Sterilization   More FDA Info for this Device
510(K) Number	K002937
Device Name	Indicator, Sterilization
Applicant	ALBERT BROWNE LTD. 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	CYNTHIA J.M. NOLTE Other 510(k) Applications for this Contact
Regulation Number	880.2800   More FDA Info for this Regulation Number
Classification Product Code	LRT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/21/2000
Decision Date	11/05/2001
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