FDA 510(k) Application Details - K142903

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K142903
Device Name	Laparoscope, General & Plastic Surgery
Applicant	NEOSURGICAL LTD BLOCK 12 GALWAY TECHNOLOGY PARK, PARKMORE GALWAY EI IE Other 510(k) Applications for this Company
Contact	Oria Brennan 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	10/06/2014
Decision Date	11/12/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review