| 510(k) Number |
K861219 |
| Device Name |
ACCUPAC CUSTOM SKIN SCRUB KIT |
| Applicant |
| Geneva Laboratories, Inc. |
| P.O. Box 444 |
|
Elkhorn,
WI
53121
|
|
| Applicant Contact |
GARY L SWANSON |
| Correspondent |
| Geneva Laboratories, Inc. |
| P.O. Box 444 |
|
Elkhorn,
WI
53121
|
|
| Correspondent Contact |
GARY L SWANSON |
| Date Received | 04/01/1986 |
| Decision Date | 04/15/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|