FDA 510(k) Application Details - K192499

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K192499
Device Name	Laparoscope, General & Plastic Surgery
Applicant	Sidam s.r.l Via Statale Sud, 169 Mirandola (BO) 41037 IT Other 510(k) Applications for this Company
Contact	Andrea Tromba 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	09/11/2019
Decision Date	07/31/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review