The following data is part of a premarket notification filed by E. Benson Hood Lab, Inc. with the FDA for Eliachar Laryngeal Foam Stent, Model Ell-1.
| Device ID | K000154 |
| 510k Number | K000154 |
| Device Name: | ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1 |
| Classification | Prosthesis, Larynx (stents And Keels) |
| Applicant | E. BENSON HOOD LAB, INC. 575 WASHINGTON ST. Pembroke, MA 02359 |
| Contact | Anthony M Sacchetti |
| Correspondent | Anthony M Sacchetti E. BENSON HOOD LAB, INC. 575 WASHINGTON ST. Pembroke, MA 02359 |
| Product Code | FWN |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-19 |
| Decision Date | 2000-03-29 |