Device Classification Name |
prosthesis, partial ossicular replacement
|
510(k) Number |
K802873 |
Device Name |
SHEA LOCKING BAIL PROSTHESIS |
Applicant |
RICHARD'S MEDICAL EQUIP., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
RICHARD'S MEDICAL EQUIP., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 874.3450
|
Classification Product Code |
|
Date Received | 11/14/1980 |
Decision Date | 12/19/1980 |
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
|
|
|