Device Classification Name |
prosthesis, laryngeal (taub)
|
510(k) Number |
K854118 |
Device Name |
DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS |
Applicant |
DACOMED CORP. |
1701 E. 79TH ST., STE. 17 |
MINNEAPOLIS,
MN
55425
|
|
Applicant Contact |
MICHAEL W WALSH |
Correspondent |
DACOMED CORP. |
1701 E. 79TH ST., STE. 17 |
MINNEAPOLIS,
MN
55425
|
|
Correspondent Contact |
MICHAEL W WALSH |
Regulation Number | 874.3730
|
Classification Product Code |
|
Date Received | 10/09/1985 |
Decision Date | 03/17/1986 |
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
|
|
|