Device Classification Name |
Prosthesis, Partial Ossicular Replacement
|
510(k) Number |
K915121 |
Device Name |
TEF/WIRE PISTON |
Applicant |
RIVER MEDICAL, INC. |
P.O.BOX 30517 |
MEMPHIS,
TN
38130
|
|
Applicant Contact |
GEORGE MURRAY |
Correspondent |
RIVER MEDICAL, INC. |
P.O.BOX 30517 |
MEMPHIS,
TN
38130
|
|
Correspondent Contact |
GEORGE MURRAY |
Regulation Number | 874.3450
|
Classification Product Code |
|
Date Received | 11/13/1991 |
Decision Date | 12/23/1991 |
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
|
|
|