The following data is part of a premarket notification filed by Broncus Technologies, Inc. with the FDA for Bronchial Catheter System.
| Device ID | K980046 |
| 510k Number | K980046 |
| Device Name: | BRONCHIAL CATHETER SYSTEM |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | BRONCUS TECHNOLOGIES, INC. 1400N SHORELINE BLVD. BLDG. A, SUITE 8 Mountain View, CA 94043 |
| Contact | Glendon E French |
| Correspondent | Glendon E French 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 | 1998-01-06 |
| Decision Date | 1998-05-01 |
| Summary: | summary |