FDA 510(k) Application Details - K192228

Device Classification Name	More FDA Info for this Device
510(K) Number	K192228
Device Name	CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant
Applicant	CS Medical L.L.C. 2179 East Lyon Station Road Creedmoor, NC 27522 US Other 510(k) Applications for this Company
Contact	Kendall Ashe Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PSW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/16/2019
Decision Date	04/01/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review