The following data is part of a premarket notification filed by Foundry Newco X, Inc. with the FDA for Microwave Tissue Coagulation System (mtcs).
| Device ID | K072870 |
| 510k Number | K072870 |
| Device Name: | MICROWAVE TISSUE COAGULATION SYSTEM (MTCS) |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | FOUNDRY NEWCO X, INC. 199 JEFFERSON DRIVE Menlo Park, CA 94025 |
| Contact | Gregory Mathison |
| Correspondent | Gregory Mathison FOUNDRY NEWCO X, INC. 199 JEFFERSON DRIVE Menlo Park, CA 94025 |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-09 |
| Decision Date | 2008-01-14 |
| Summary: | summary |