FDA 510(k) Application Details - K991618

Device Classification Name	Indicator, Biological Sterilization Process   More FDA Info for this Device
510(K) Number	K991618
Device Name	Indicator, Biological Sterilization Process
Applicant	PROPPER MFG. CO., INC. 36-04 SKILLMAN AVE. LONG ISLAND CITY, NY 11101 US Other 510(k) Applications for this Company
Contact	JOHN D DYCKMAN Other 510(k) Applications for this Contact
Regulation Number	880.2800   More FDA Info for this Regulation Number
Classification Product Code	FRC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/11/1999
Decision Date	01/24/2001
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