| 510(k) Number |
K828673 |
| Device Name |
RICH-MAR ULTRASOUND COUPLING LOTION |
| Applicant |
| Whs Products, Inc. |
| 3312b S. Peoria |
|
Tulsa,
OK
74105
|
|
| Correspondent |
| Whs Products, Inc. |
| 3312b S. Peoria |
|
Tulsa,
OK
74105
|
|
| Date Received | 11/16/1982 |
| Decision Date | 01/19/1983 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|