Device Classification Name |
replacement, ossicular prosthesis, total
|
510(k) Number |
K885201 |
Device Name |
OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT |
Applicant |
MICROBIO-MEDICS, INC. |
POST OFFICE BOX 2487 |
COLUMBUS,
MS
39704
|
|
Applicant Contact |
KEITH MCGEE |
Correspondent |
MICROBIO-MEDICS, INC. |
POST OFFICE BOX 2487 |
COLUMBUS,
MS
39704
|
|
Correspondent Contact |
KEITH MCGEE |
Regulation Number | 874.3495
|
Classification Product Code |
|
Date Received | 12/16/1988 |
Decision Date | 04/19/1989 |
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
|
|
|