Device Classification Name |
laparoscope, gynecologic (and accessories)
|
510(k) Number |
K173111 |
Device Name |
LAP-iX Suction Irrigation |
Applicant |
Sejong Medical Co., Ltd. |
11, Sinchon 2-ro |
Paju-si,
KR
10880
|
|
Applicant Contact |
Yoojung Choi |
Correspondent |
LK Consulting Group USA, Inc. |
690 Roosevelt |
690 Roosevelt,
CA
92620
|
|
Correspondent Contact |
Priscilla Chung |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 09/29/2017 |
Decision Date | 11/28/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|