The following data is part of a premarket notification filed by Transmed7, Llc with the FDA for Speedbird Model Sb38 Soft Tissue Biopsy Device; Speedbird Model Sbu Soft Tissue Biopsy Device; Speedbird Model Sbu99 Soft Tissue Biopsy Device.
| Device ID | K173316 |
| 510k Number | K173316 |
| Device Name: | SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-19 |
| Decision Date | 2018-06-19 |
| Summary: | summary |