The following data is part of a premarket notification filed by Daesung Maref Co., Ltd. with the FDA for Dvt-4000s.
| Device ID | K203417 |
| 510k Number | K203417 |
| Device Name: | DVT-4000S |
| Classification | Sleeve, Limb, Compressible |
| Applicant | Daesung Maref CO., LTD. 298-24, Gongdan-Ro Gunpo-si, KR 15809 |
| Contact | Su Hyeon So |
| Correspondent | Su Hyeon So Daesung Maref CO., LTD. 298-24, Gongdan-Ro Gunpo-si, KR 15809 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-19 |
| Decision Date | 2021-03-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18809315675663 | K203417 | 000 |
| 08809315675314 | K203417 | 000 |