FDA 510(k) Application Details - K141606

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K141606
Device Name	Gown, Surgical
Applicant	COBES INDUSTRIES CO., LTD. 23 DENGLIANG ROAD HANKING CENTER 7E-011 SHENZHEN, GUANGDONG 518052 CN Other 510(k) Applications for this Company
Contact	LYNN FU Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FYA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/16/2014
Decision Date	11/17/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review