The following data is part of a premarket notification filed by Transmed7, Llc with the FDA for Concorde Models Concorde Us And Concorde St Soft Tissue Biopsy Devices.
| Device ID | K201244 |
| 510k Number | K201244 |
| Device Name: | Concorde Models Concorde US And Concorde ST Soft Tissue Biopsy Devices |
| Classification | Instrument, Biopsy |
| Applicant | TransMed7, LLC 117 Solana Road Portola Valley, CA 94028 |
| Contact | James Vetter |
| Correspondent | James Vetter TransMed7, LLC 117 Solana Road Portola Valley, CA 94028 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-08 |
| Decision Date | 2020-08-07 |