The following data is part of a premarket notification filed by Sejong Medical Co., Ltd. with the FDA for Lapbag.
Device ID | K171726 |
510k Number | K171726 |
Device Name: | LapBag |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | Sejong Medical Co., Ltd. 11, Sinchon 2-ro Paju-si, KR 10880 |
Contact | Yoojung Choi |
Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt Irvine, CA 92620 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-06-12 |
Decision Date | 2017-09-25 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LAPBAG 75661049 not registered Dead/Abandoned |
Lapbags, Incorporated 1999-03-18 |