FDA 510(k) Application Details - K151832

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K151832
Device Name	Laparoscope, General & Plastic Surgery
Applicant	NOVATECH S.A. Z.I. ATHELIA III - 1058, VOIE ANTIOPE LA CIOTAT CEDEX 13705 FR Other 510(k) Applications for this Company
Contact	JENNIFER NEFF 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	07/06/2015
Decision Date	03/31/2016
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