Device Classification Name |
System, Vocal Cord Medialization
|
510(k) Number |
K180631 |
Device Name |
Silk Voice |
Applicant |
Sofregen Medical, Inc. |
200 Boston Avenue, Suite 1100 |
Medford,
MA
02155
|
|
Applicant Contact |
Anh Hoang |
Correspondent |
Sofregen Medical, Inc. |
200 Boston Avenue, Suite 1100 |
Medford,
MA
02155
|
|
Correspondent Contact |
Anh Hoang |
Regulation Number | 874.3620
|
Classification Product Code |
|
Date Received | 03/09/2018 |
Decision Date | 11/08/2018 |
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
|
|
|