| 510(k) Number |
K840036 |
| Device Name |
FITEX |
| Applicant |
| Britt Corp., Inc. |
|
Chanhassen ,
MN
55317
|
|
| Applicant Contact |
AXEL M FRITZ |
| Correspondent |
| Britt Corp., Inc. |
|
Chanhassen ,
MN
55317
|
|
| Correspondent Contact |
AXEL M FRITZ |
| Date Received | 01/05/1984 |
| Decision Date | 10/26/1984 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Physical Medicine
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|