The following data is part of a premarket notification filed by Neuwave Medical, Inc with the FDA for Certus 140 Microwave Ablation System And Accessories, Model Certus 140.
| Device ID | K100744 |
| 510k Number | K100744 |
| Device Name: | CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140 |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | NEUWAVE MEDICAL, INC 3529 ANDERSON STREET Madison, WI 53704 |
| Contact | Daniel Kosednar |
| Correspondent | Daniel 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 | 2010-03-16 |
| Decision Date | 2010-10-22 |
| Summary: | summary |