Device Classification Name |
irrigator, sinus
|
510(k) Number |
K131177 |
Device Name |
SINUFLUSH LAVAGE SYSTEM |
Applicant |
HEDGEPATH, LLC |
324 S. HYDE PARK AVE. SUITE 350 |
TAMPA,
FL
33606
|
|
Applicant Contact |
FRANK E O'DONNELL, JR MD. |
Correspondent |
HEDGEPATH, LLC |
324 S. HYDE PARK AVE. SUITE 350 |
TAMPA,
FL
33606
|
|
Correspondent Contact |
FRANK E O'DONNELL, JR MD. |
Regulation Number | 874.4420
|
Classification Product Code |
|
Date Received | 04/25/2013 |
Decision Date | 09/20/2013 |
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
|
|
|