Device Classification Name |
splint, intranasal septal
|
510(k) Number |
K122494 |
Device Name |
POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT |
Applicant |
HEMOSTASIS, LLC |
5000 Township Pkwy |
Saint Paul,
MN
55110
|
|
Applicant Contact |
BERNARD HORWATH |
Correspondent |
HEMOSTASIS, LLC |
5000 Township Pkwy |
Saint Paul,
MN
55110
|
|
Correspondent Contact |
BERNARD HORWATH |
Regulation Number | 874.4780
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/16/2012 |
Decision Date | 03/27/2013 |
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
|
|
|