510(k) K894380
- Device
- DUMON TRACHEOBRONCHIAL STENT
- Applicant
- BRYAN CORP.
- 510(k) number
- K894380
- Product code
- NWA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-10-24
- Date received
- 1989-07-17
- Regulation
- 878.3720
- Classification name
- Prosthesis, Tracheal, Preformed/molded
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- FRANK M ABRANO
- Address
- Four Plympton St. Woburn MA US 01801 01801
FDA Registration Numbers#
- 9613846
- 1220850
- 3010197296
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NWA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243126 | TRACHEOBRONXANE™ DUMON® | Novatech SA | 2024-10-29 |
| K213969 | VisionAir Patient-Specific Airway Stent | New Cos Inc. Dba Visionair Solutions | 2022-10-07 |
| K182743 | Patient-Specific Airway Stent | New Cos, Inc. | 2019-10-23 |
| K971509 | ENDOXANE | Novatech SA | 1997-08-21 |
| K873742 | HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES | Hood Laboratories | 1987-10-01 |
Legacy Summary#
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FDA Review#
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