Device Classification Name |
Splint, Intranasal Septal
|
510(k) Number |
K213153 |
Device Name |
SPIWay Endonasal Access Guide |
Applicant |
SPIWay, LLC |
3600 Corte Castillo |
Carlsbad,
CA
92009
|
|
Applicant Contact |
Eugene Chen |
Correspondent |
SPIWay, LLC |
3600 Corte Castillo |
Carlsbad,
CA
92009
|
|
Correspondent Contact |
Mary Lou Mooney |
Regulation Number | 874.4780
|
Classification Product Code |
|
Date Received | 09/28/2021 |
Decision Date | 10/27/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|