Device Classification Name |
Prosthesis, Partial Ossicular Replacement
|
510(k) Number |
K895814 |
Device Name |
MICROTEK PISTON & WIRE PROSTHESES |
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 | 874.3450
|
Classification Product Code |
|
Date Received | 09/29/1989 |
Decision Date | 12/26/1989 |
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
|
|
|