The following data is part of a premarket notification filed by Neuwave Medical, Inc. with the FDA for Certus 140 Certusurggt Surgical Tool.
| Device ID | K130399 |
| 510k Number | K130399 |
| Device Name: | CERTUS 140 CERTUSURGGT SURGICAL TOOL |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | NEUWAVE MEDICAL, INC. 3529 Anderson St Madison, WI 53704 |
| Contact | Dan Kosednar |
| Correspondent | Dan Kosednar NEUWAVE MEDICAL, INC. 3529 Anderson St 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 | 2013-02-19 |
| Decision Date | 2013-07-18 |
| Summary: | summary |