Device Classification Name |
Polymer, Ear, Nose And Throat, Synthetic, Absorbable
|
510(k) Number |
K132920 |
Device Name |
SPIROX INEX DEVICE |
Applicant |
SPIROX, INC. |
381 ARLINGTON WAY |
MENLO PARK,
CA
94025
|
|
Applicant Contact |
MIKE ROSENTHAL |
Correspondent |
SPIROX, INC. |
381 ARLINGTON WAY |
MENLO PARK,
CA
94025
|
|
Correspondent Contact |
MIKE ROSENTHAL |
Regulation Number | 874.3620
|
Classification Product Code |
|
Date Received | 09/17/2013 |
Decision Date | 06/10/2014 |
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
|
|
|