| Device Classification Name |
Support, Arm
|
| 510(k) Number |
K770065 |
| Device Name |
ADJUSTABLE ARM SUPPORT |
| Applicant |
| Richard F. Kronner, M.D. |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Correspondent |
| Richard F. Kronner, M.D. |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Regulation Number | 890.3475 |
| Classification Product Code |
|
| Date Received | 01/12/1977 |
| Decision Date | 02/02/1977 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|