The following data is part of a premarket notification filed by Daesung Maref Co., Ltd. with the FDA for The Venous Assist System.
| Device ID | K112677 |
| 510k Number | K112677 |
| Device Name: | THE VENOUS ASSIST SYSTEM |
| Classification | Sleeve, Limb, Compressible |
| Applicant | DAESUNG MAREF CO., LTD. 4568 WEST 1ST STREET SUITE 104 Los Angeles, CA 90004 |
| Contact | Daniel Nam |
| Correspondent | Daniel Nam DAESUNG MAREF CO., LTD. 4568 WEST 1ST STREET SUITE 104 Los Angeles, CA 90004 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-14 |
| Decision Date | 2012-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28809315678395 | K112677 | 000 |
| 38809315678613 | K112677 | 000 |
| 38809315678590 | K112677 | 000 |
| 38809315678576 | K112677 | 000 |
| 38809315678538 | K112677 | 000 |
| 08809315678513 | K112677 | 000 |
| 38809315678477 | K112677 | 000 |
| 38809315678453 | K112677 | 000 |
| 38809315678439 | K112677 | 000 |
| 08809315678414 | K112677 | 000 |
| 38809315678637 | K112677 | 000 |
| 38809315678699 | K112677 | 000 |
| 38809315678736 | K112677 | 000 |
| 38809315678835 | K112677 | 000 |
| 08809315678490 | K112677 | 000 |
| 38809315678811 | K112677 | 000 |
| 38809315678774 | K112677 | 000 |
| 38809315678712 | K112677 | 000 |
| 38809315678651 | K112677 | 000 |
| 38809315678910 | K112677 | 000 |
| 38809315678798 | K112677 | 000 |
| 38809315678750 | K112677 | 000 |
| 08809315678384 | K112677 | 000 |