The following data is part of a premarket notification filed by Bryan Corp. with the FDA for Dumon Tracheobronchial Stent.
| Device ID | K894380 |
| 510k Number | K894380 |
| Device Name: | DUMON TRACHEOBRONCHIAL STENT |
| Classification | Prosthesis, Tracheal, Preformed/molded |
| 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 | NWA |
| CFR Regulation Number | 878.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-17 |
| Decision Date | 1989-10-24 |