FDA 510(k) Application Details - K133345

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K133345
Device Name	Laparoscope, General & Plastic Surgery
Applicant	RETRACTION LIMITED UNIT F, 2/F, HONG KONG INDUSTRIAL BLDG 444-452 DES VOEUX ROAD WEST SAI WAN, HONG KONG 999077 CN Other 510(k) Applications for this Company
Contact	STUART MORAN Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	GCJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/30/2013
Decision Date	04/11/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review