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 |