FDA 510(k) Application Details - K100195

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K100195
Device Name	Laparoscope, General & Plastic Surgery
Applicant	NDS SURGICAL IMAGING 5750 HELLYER AVENUE SAN JOSE, CA 95138 US Other 510(k) Applications for this Company
Contact	JIM LENG 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	01/22/2010
Decision Date	04/21/2010
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	Y
Expedited Review