The following data is part of a premarket notification filed by Neuwave Medical, Inc. with the FDA for Neuwave Microwave Ablation System And Accessories.
| Device ID | K200081 |
| 510k Number | K200081 |
| Device Name: | NEUWAVE Microwave Ablation System And Accessories |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | NeuWave Medical, Inc. 3529 Anderson Street Madison, WI 53704 |
| Contact | Dan Kosednar |
| Correspondent | Dan Kosednar NeuWave Medical, Inc. 3529 Anderson Street Madison, WI 53704 |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-15 |
| Decision Date | 2020-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818913020506 | K200081 | 000 |
| 00818913020523 | K200081 | 000 |