Device Classification Name |
Prosthesis, Laryngeal (Taub)
|
510(k) Number |
K812864 |
Device Name |
SILASTIC VOICE PROSTHESIS |
Applicant |
DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 874.3730
|
Classification Product Code |
|
Date Received | 10/13/1981 |
Decision Date | 11/24/1981 |
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
|
|
|