FDA 510(k) Application Details - K193026

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K193026
Device Name	Laparoscope, General & Plastic Surgery
Applicant	Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-Shi 192-8507 JP Other 510(k) Applications for this Company
Contact	Toshiyuki Nakajima 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	10/30/2019
Decision Date	04/03/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review