FDA 510(k) Application Details - K133080

Device Classification Name	Drape, Surgical   More FDA Info for this Device
510(K) Number	K133080
Device Name	Drape, Surgical
Applicant	FOSHAN NANHAI PLUS MEDICAL CO., LTD. 3500 SOUTH DUPONT HIGHWAY DOVER, DE 19901 US Other 510(k) Applications for this Company
Contact	LEON LU 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	09/30/2013
Decision Date	06/24/2015
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