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 |