FDA 510(k) Application Details - K141467

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K141467
Device Name	Gown, Surgical
Applicant	XUCHANG ZHENGDE ENVIRONSTAR MEDICAL PRODUCTS CO.,L 7TH FOOR JINGUI BUSINESS BUILDING NO.982 CONGYM RD. BAIYM DISTRICT GUANGZHOU, GUANGDONG 510420 CN Other 510(k) Applications for this Company
Contact	MIKE GU Other 510(k) Applications for this Contact
Regulation Number	878.4040   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	06/03/2014
Decision Date	03/05/2015
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