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 |