Device Classification Name |
Irrigator, Powered Nasal
|
510(k) Number |
K140542 |
Device Name |
NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER |
Applicant |
RHINOSYSTEMS, INC. |
5399 Lancaster Dr # 6 |
Brooklyn Heights,
OH
44131
|
|
Applicant Contact |
MARTIN R HOKE |
Correspondent |
RHINOSYSTEMS, INC. |
5399 Lancaster Dr # 6 |
Brooklyn Heights,
OH
44131
|
|
Correspondent Contact |
MARTIN R HOKE |
Regulation Number | 874.5550
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/04/2014 |
Decision Date | 06/27/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|