The following data is part of a premarket notification filed by Microsurgeon, Inc. with the FDA for Microsurgeon Microwave Tissue Ablation Device, Model Mtad-200.
| Device ID | K082565 |
| 510k Number | K082565 |
| Device Name: | MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-200 |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | MICROSURGEON, INC. 20363 EAST TULIP CIRCLE Montrose, CO 81403 |
| Contact | Dudley Harris |
| Correspondent | Dudley Harris MICROSURGEON, INC. 20363 EAST TULIP CIRCLE Montrose, CO 81403 |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-04 |
| Decision Date | 2009-02-12 |
| Summary: | summary |