Device Classification Name |
masker, tinnitus
|
510(k) Number |
K940567 |
Device Name |
MODEL#1550 MARSONA(R) TINNITUS MASKER |
Applicant |
MARPAC, INC. |
2907 BLUE CLAY RD. |
P.O. BOX 3098 |
WILMINGTON,
NC
28406
|
|
Applicant Contact |
DAVID A THEISEN |
Correspondent |
MARPAC, INC. |
2907 BLUE CLAY RD. |
P.O. BOX 3098 |
WILMINGTON,
NC
28406
|
|
Correspondent Contact |
DAVID A THEISEN |
Regulation Number | 874.3400
|
Classification Product Code |
|
Date Received | 02/08/1994 |
Decision Date | 07/06/1994 |
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
|
|
|