Device Classification Name |
larynx, artificial (battery-powered)
|
510(k) Number |
K831127 |
Device Name |
INTRA-ORAL ARTIFICIAL LARYNX |
Applicant |
XOMED, INC. |
1318 LONEDELL RD. |
ARNOLD,
MO
63010
|
|
Correspondent |
XOMED, INC. |
1318 LONEDELL RD. |
ARNOLD,
MO
63010
|
|
Regulation Number | 874.3375
|
Classification Product Code |
|
Date Received | 04/06/1983 |
Decision Date | 07/28/1983 |
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
|
|
|