FDA 510(k) Application Details - K130001

Device Classification Name	Apparatus, Suction, Ward Use, Portable, Ac-Powered   More FDA Info for this Device
510(K) Number	K130001
Device Name	Apparatus, Suction, Ward Use, Portable, Ac-Powered
Applicant	FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. THE 2F AND 3F, G BUILDING, NO.1 HUABAO ROAD SOUTHERN FOSHAN, GUANGDONG 528000 CN Other 510(k) Applications for this Company
Contact	GANG WU Other 510(k) Applications for this Contact
Regulation Number	878.4780   More FDA Info for this Regulation Number
Classification Product Code	JCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/2013
Decision Date	07/25/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review