Device Classification Name |
Button, Nasal Septal
|
510(k) Number |
K013696 |
Device Name |
SILMED NASAL SEPTAL BUTTON |
Applicant |
SILMED, INC. |
3987 LAKEVIEW TRAIL |
LEESBURG,,
IN
46538
|
|
Applicant Contact |
RAMA GUNDLAPALLI |
Correspondent |
SILMED, INC. |
3987 LAKEVIEW TRAIL |
LEESBURG,,
IN
46538
|
|
Correspondent Contact |
RAMA GUNDLAPALLI |
Classification Product Code |
|
Date Received | 11/07/2001 |
Decision Date | 11/28/2001 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|