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 |