The following data is part of a premarket notification filed by Daesung Maref Co., Ltd with the FDA for Dvt-pro.
| Device ID | K203353 |
| 510k Number | K203353 |
| Device Name: | DVT-PRO |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-13 |
| Decision Date | 2021-04-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18809315679906 | K203353 | 000 |
| 08809315679824 | K203353 | 000 |
| 18809315679838 | K203353 | 000 |
| 18809315679845 | K203353 | 000 |
| 08809315679855 | K203353 | 000 |
| 18809315679869 | K203353 | 000 |
| 18809315679876 | K203353 | 000 |
| 18809315679883 | K203353 | 000 |
| 18809315679890 | K203353 | 000 |
| 18809802644455 | K203353 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DVT-PRO 86934673 5423973 Live/Registered |
DAESUNG MAREF CO., LTD. 2016-03-09 |