FDA 510(k) Application Details - K012889

Device Classification Name	Sterilant, Medical Devices   More FDA Info for this Device
510(K) Number	K012889
Device Name	Sterilant, Medical Devices
Applicant	PASCAL CO., INC. 1001 G STREET, N.W. SUITE 500 WEST WASHINGTON, DC 20001 US Other 510(k) Applications for this Company
Contact	DAVID R JOY Other 510(k) Applications for this Contact
Regulation Number	880.6885   More FDA Info for this Regulation Number
Classification Product Code	MED Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/28/2001
Decision Date	05/27/2003
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