Device Classification Name |
Prosthesis, Laryngeal (Taub)
|
510(k) Number |
K022125 |
Device Name |
PROVOX FREEHANDS HME, MODEL 7710 |
Applicant |
ATOS MEDICAL AB |
KRAFTGATAN 8 |
P.O.BOX 183 |
HORBY,
SE
SE-242 22
|
|
Applicant Contact |
EDDY ABERG |
Correspondent |
ATOS MEDICAL AB |
KRAFTGATAN 8 |
P.O.BOX 183 |
HORBY,
SE
SE-242 22
|
|
Correspondent Contact |
EDDY ABERG |
Regulation Number | 874.3730
|
Classification Product Code |
|
Date Received | 07/01/2002 |
Decision Date | 07/30/2002 |
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
|
|
|