| 510(k) Number |
K843203 |
| Device Name |
CRYO MASSAGE CUP |
| Applicant |
| Cryo Therapy |
| P.O. Box 415 |
|
Monticelo,
MN
55362
|
|
| Applicant Contact |
NICOLAI |
| Correspondent |
| Cryo Therapy |
| P.O. Box 415 |
|
Monticelo,
MN
55362
|
|
| Correspondent Contact |
NICOLAI |
| Date Received | 08/14/1984 |
| Decision Date | 11/14/1984 |
| 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
|
|
|