Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K171726 |
Device Name |
LapBag |
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 |
Irvine,
CA
92620
|
|
Correspondent Contact |
Priscilla Chung |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/12/2017 |
Decision Date | 09/25/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|