Device Classification Name |
larynx, artificial (battery-powered)
|
510(k) Number |
K854158 |
Device Name |
RESNICK EMITTER, ARTIFICIAL LARYNX |
Applicant |
DYNAMED AUDIO, INC. |
R.D. 1 BOX 415A |
NATRONA HEIGHTS,
PA
15065
|
|
Applicant Contact |
JOSEPH A RESNICK |
Correspondent |
DYNAMED AUDIO, INC. |
R.D. 1 BOX 415A |
NATRONA HEIGHTS,
PA
15065
|
|
Correspondent Contact |
JOSEPH A RESNICK |
Regulation Number | 874.3375
|
Classification Product Code |
|
Date Received | 10/11/1985 |
Decision Date | 12/13/1985 |
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
|
|
|