The following data is part of a premarket notification filed by Broncus Technologies, Inc. with the FDA for Coagulation Electrode, Model 2000; Radiofrequency Generator, Model 20-115.
Device ID | K993900 |
510k Number | K993900 |
Device Name: | COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MODEL 20-115 |
Classification | Bronchoscope (flexible Or Rigid) |
Applicant | BRONCUS TECHNOLOGIES, INC. 1400N SHORELINE BLVD. BLDG. A, SUITE 8 Mountain View, CA 94043 |
Contact | John D'angelo |
Correspondent | John D'angelo BRONCUS TECHNOLOGIES, INC. 1400N SHORELINE BLVD. BLDG. A, SUITE 8 Mountain View, CA 94043 |
Product Code | EOQ |
CFR Regulation Number | 874.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-11-16 |
Decision Date | 2000-01-28 |
Summary: | summary |