FDA 510(k) Application Details - K112136

Device Classification Name	Drape, Surgical   More FDA Info for this Device
510(K) Number	K112136
Device Name	Drape, Surgical
Applicant	KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD. 1340 WEST PENNSYLVANIA AVE SAN DIEGO, CA 92103 US Other 510(k) Applications for this Company
Contact	Glen Feye 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	07/26/2011
Decision Date	09/29/2011
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