FDA 510(k) Application Details - K200238

Device Classification Name	Drape, Surgical   More FDA Info for this Device
510(K) Number	K200238
Device Name	Drape, Surgical
Applicant	ControlRad, Inc 275 Scientific Drive NW #1100 Norcross, GA 30092 US Other 510(k) Applications for this Company
Contact	Chris Fair Other 510(k) Applications for this Contact
Regulation Number	878.4370   More FDA Info for this Regulation Number
Classification Product Code	KKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/31/2020
Decision Date	04/26/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review