The following data is part of a premarket notification filed by Sejong Medical Co., Ltd. with the FDA for Smoklean.
| Device ID | K173108 |
| 510k Number | K173108 |
| Device Name: | Smoklean |
| Classification | Apparatus, Exhaust, Surgical |
| 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 | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2018-05-18 |
| Summary: | summary |