The following data is part of a premarket notification filed by Microtek Medical, Inc. with the FDA for Venodyne V810.
| Device ID | K110358 |
| 510k Number | K110358 |
| Device Name: | VENODYNE V810 |
| Classification | Sleeve, Limb, Compressible |
| Applicant | MICROTEK MEDICAL, INC. 602 LEHMBERG RD. Columbus, MS 39702 |
| Contact | Tom Bonner |
| Correspondent | Tom Bonner MICROTEK MEDICAL, INC. 602 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 | 2011-02-07 |
| Decision Date | 2011-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50748426060400 | K110358 | 000 |
| 50748426111010 | K110358 | 000 |
| 50748426089449 | K110358 | 000 |
| 50748426091336 | K110358 | 000 |
| 50748426091329 | K110358 | 000 |
| 50748426081849 | K110358 | 000 |