FDA 510(k) Application Details - K974304

Device Classification Name	Disinfectant, Medical Devices   More FDA Info for this Device
510(K) Number	K974304
Device Name	Disinfectant, Medical Devices
Applicant	CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 5035 MANCHESTER AVE. ST. LOUIS, MO 63110 US Other 510(k) Applications for this Company
Contact	MIKE EBERS Other 510(k) Applications for this Contact
Regulation Number	880.6890   More FDA Info for this Regulation Number
Classification Product Code	LRJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/17/1997
Decision Date	01/13/1998
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