Device Classification Name |
Prosthesis, Larynx (Stents And Keels)
|
510(k) Number |
K000154 |
Device Name |
ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1 |
Applicant |
E. BENSON HOOD LAB, INC. |
575 WASHINGTON ST. |
PEMBROKE,
MA
02359
|
|
Applicant Contact |
ANTHONY M SACCHETTI |
Correspondent |
E. BENSON HOOD LAB, INC. |
575 WASHINGTON ST. |
PEMBROKE,
MA
02359
|
|
Correspondent Contact |
ANTHONY M SACCHETTI |
Regulation Number | 874.3620
|
Classification Product Code |
|
Date Received | 01/19/2000 |
Decision Date | 03/29/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|