Device Classification Name |
replacement, ossicular prosthesis, total
|
510(k) Number |
K083780 |
Device Name |
SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2 |
Applicant |
AUDIO TECHNOLOGIES S.R.L. |
VIA VALLERA, 42 |
PIACENZA,
IT
I-29100
|
|
Applicant Contact |
FRANCO BEONI |
Correspondent |
AUDIO TECHNOLOGIES S.R.L. |
VIA VALLERA, 42 |
PIACENZA,
IT
I-29100
|
|
Correspondent Contact |
FRANCO BEONI |
Regulation Number | 874.3495
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/19/2008 |
Decision Date | 03/23/2009 |
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
|
|
|