The following data is part of a premarket notification filed by Broncus Technologies, Inc. with the FDA for Yield Tissue Sampler.
| Device ID | K090853 |
| 510k Number | K090853 |
| Device Name: | YIELD TISSUE SAMPLER |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | BRONCUS TECHNOLOGIES, INC. 1400 N. SHORELINE BLVD. BLDG A SUITE 8 Mountain Veiw, CA 94043 |
| Contact | Nancy Isaac |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-03-30 |
| Decision Date | 2009-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856571007210 | K090853 | 000 |
| 00856571007012 | K090853 | 000 |