FDA 510(k) Application Details - K173111

Device Classification Name	Laparoscope, Gynecologic (And Accessories)   More FDA Info for this Device
510(K) Number	K173111
Device Name	Laparoscope, Gynecologic (And Accessories)
Applicant	Sejong Medical Co., Ltd. 11, Sinchon 2-ro Paju-si 10880 KR Other 510(k) Applications for this Company
Contact	Yoojung Choi Other 510(k) Applications for this Contact
Regulation Number	884.1720   More FDA Info for this Regulation Number
Classification Product Code	HET Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2017
Decision Date	11/28/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review