FDA 510(k) Application Details - K140195

Device Classification Name	Drape, Surgical   More FDA Info for this Device
510(K) Number	K140195
Device Name	Drape, Surgical
Applicant	GRIFFITH-LUCAS LLC 7TH FLOOR, JINGUI BUSINESS BUILDING NO.982 CONGYUN RD, BAIYUN DISTRICT GUANGZHOU, GUANGDONG 510420 CN Other 510(k) Applications for this Company
Contact	MIKE GU 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	01/27/2014
Decision Date	09/10/2014
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