Device Classification Name |
prosthesis, laryngeal (taub)
|
510(k) Number |
K141380 |
Device Name |
PROVOX FREEHANDS FLEXIVOICE |
Applicant |
ATOS MEDICAL AB |
KRAFTGATAN 8 |
HORBY,
SE
SE-24222
|
|
Applicant Contact |
FERENC DAHNER |
Correspondent |
ATOS MEDICAL AB |
KRAFTGATAN 8 |
HORBY,
SE
SE-24222
|
|
Correspondent Contact |
FERENC DAHNER |
Regulation Number | 874.3730
|
Classification Product Code |
|
Date Received | 05/27/2014 |
Decision Date | 09/26/2014 |
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
|
|
|