Device Classification Name |
System, Vocal Cord Medialization
|
510(k) Number |
K150400 |
Device Name |
Renu Gel |
Applicant |
CYTOPHIL, INC. |
2485 CORPORATE CIRCLE SUITE 2 |
EAST TROY,
WI
53120
|
|
Applicant Contact |
BOB VOIGTS |
Correspondent |
CYTOPHIL, INC. |
2485 CORPORATE CIRCLE SUITE 2 |
EAST TROY,
WI
53120
|
|
Correspondent Contact |
BOB VOIGTS |
Regulation Number | 874.3620
|
Classification Product Code |
|
Date Received | 02/18/2015 |
Decision Date | 04/06/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|