Device Classification Name |
Dilator, Nasal
|
510(k) Number |
K955711 |
Device Name |
BREATHE RIGHT NASAL STRIP |
Applicant |
CNS, INC. |
P.O. BOX 39802 |
MINNEAPOLIS,
MN
55439 -0802
|
|
Applicant Contact |
M.W. (ANDY) ANDERSON |
Correspondent |
CNS, INC. |
P.O. BOX 39802 |
MINNEAPOLIS,
MN
55439 -0802
|
|
Correspondent Contact |
M.W. (ANDY) ANDERSON |
Regulation Number | 874.3900
|
Classification Product Code |
|
Date Received | 12/18/1995 |
Decision Date | 05/30/1996 |
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
|
|
|