The following data is part of a premarket notification filed by Microtek Medical, Inc. with the FDA for Venodyne Dvt Advantage Model 610.
| Device ID | K001802 |
| 510k Number | K001802 |
| Device Name: | VENODYNE DVT ADVANTAGE MODEL 610 |
| Classification | Sleeve, Limb, Compressible |
| Applicant | MICROTEK MEDICAL, INC. 512 LEHMBERG RD. Columbus, MS 39702 |
| Contact | Thomas Bonner |
| Correspondent | Thomas Bonner MICROTEK MEDICAL, INC. 512 LEHMBERG RD. Columbus, MS 39702 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-14 |
| Decision Date | 2001-01-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50748426036382 | K001802 | 000 |
| 50748426036320 | K001802 | 000 |
| 50748426036337 | K001802 | 000 |
| 50748426036238 | K001802 | 000 |
| 50748426065047 | K001802 | 000 |
| 50748426065030 | K001802 | 000 |
| 50748426064309 | K001802 | 000 |