FDA 510(k) Application Details - K162059

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K162059
Device Name	Laparoscope, General & Plastic Surgery
Applicant	GENICON, INC 6869 STAPOINT COURT SUITE 114 WINTER PARK, FL 32792 US Other 510(k) Applications for this Company
Contact	KATLYN KACHMAN 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	07/26/2016
Decision Date	09/29/2016
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