Device Classification Name |
masker, tinnitus
|
510(k) Number |
K981704 |
Device Name |
AUREX-3 |
Applicant |
ADM TRONICS UNLTD, INC. |
P.O. BOX 2002 |
MORRISTOWN,
TN
37816
|
|
Applicant Contact |
JAMES E LENICK |
Correspondent |
ADM TRONICS UNLTD, INC. |
P.O. BOX 2002 |
MORRISTOWN,
TN
37816
|
|
Correspondent Contact |
JAMES E LENICK |
Regulation Number | 874.3400
|
Classification Product Code |
|
Date Received | 05/14/1998 |
Decision Date | 08/05/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|