FDA 510(k) Application Details - K984485

Device Classification Name	Disinfectant, Medical Devices   More FDA Info for this Device
510(K) Number	K984485
Device Name	Disinfectant, Medical Devices
Applicant	CHEMLINK LABORATORIES LLC. 122 C STREET, N.W., SUITE 740 WASHINGTON, DC 20001 US Other 510(k) Applications for this Company
Contact	KARI E MAVIAN 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	12/17/1998
Decision Date	01/13/1999
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