Device Classification Name |
Replacement, Ossicular Prosthesis, Total
|
510(k) Number |
K001406 |
Device Name |
HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES |
Applicant |
MEDNET LOCATOR, INC. |
7000 SHADOW OAKS |
MEMPHIS,
TN
38125
|
|
Applicant Contact |
JUDY CHANDLER |
Correspondent |
MEDNET LOCATOR, INC. |
7000 SHADOW OAKS |
MEMPHIS,
TN
38125
|
|
Correspondent Contact |
JUDY CHANDLER |
Regulation Number | 874.3495
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/03/2000 |
Decision Date | 08/08/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|