The following data is part of a premarket notification filed by Sejong Medical Co., Ltd. with the FDA for Laport.
| Device ID | K171741 |
| 510k Number | K171741 |
| Device Name: | Laport |
| 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 | 2017-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 88806182210873 | K171741 | 000 |
| 88806182210583 | K171741 | 000 |
| 88806182210514 | K171741 | 000 |
| 08806182210433 | K171741 | 000 |
| 88806182210392 | K171741 | 000 |
| 88806182210378 | K171741 | 000 |
| 88806182210330 | K171741 | 000 |