FDA 510(k) Application Details - K020612

Device Classification Name	Indicator, Physical/Chemical Sterilization Process   More FDA Info for this Device
510(K) Number	K020612
Device Name	Indicator, Physical/Chemical Sterilization Process
Applicant	SULTAN CHEMISTS, INC. 85 WEST FOREST AVE. ENGLEWOOD, NJ 07631 US Other 510(k) Applications for this Company
Contact	CLARK SMITH 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	02/25/2002
Decision Date	05/07/2002
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