The following data is part of a premarket notification filed by Bryan Corp. with the FDA for Dumon/harrell.
| Device ID | K854414 |
| 510k Number | K854414 |
| Device Name: | DUMON/HARRELL |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | BRYAN CORP. FOUR PLYMPTON ST. Woburn, MA 01801 |
| Contact | Frank M Abrano |
| Correspondent | Frank M Abrano BRYAN CORP. FOUR PLYMPTON ST. Woburn, MA 01801 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-04 |
| Decision Date | 1986-03-12 |