The following data is part of a premarket notification filed by Daesung Maref Co., Ltd. with the FDA for Venous Assist System.
| Device ID | K150980 |
| 510k Number | K150980 |
| Device Name: | Venous Assist System |
| Classification | Sleeve, Limb, Compressible |
| Applicant | DAESUNG MAREF CO., LTD. 298-24, GONGDAN-RO Gunpo-shi, KR 435-862 |
| Contact | Jae-wha Lee |
| Correspondent | Dave Kim Mtech Group 8310 Buffalo Speedway Houston, TX 77025 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-14 |
| Decision Date | 2016-05-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28809315677695 | K150980 | 000 |
| 28809315677732 | K150980 | 000 |
| 28809315677756 | K150980 | 000 |
| 28809315677718 | K150980 | 000 |
| 08809315677684 | K150980 | 000 |