| 510(k) Number |
K854893 |
| Device Name |
KEYES SKIN PUNCH |
| Applicant |
| Euro-Med Intl. |
| Advanced Biosearch Associates |
| 3880 Blackhawk Rd. |
|
Danville,
CA
94526
|
|
| Applicant Contact |
DONALD HOLSTEN |
| Correspondent |
| Euro-Med Intl. |
| Advanced Biosearch Associates |
| 3880 Blackhawk Rd. |
|
Danville,
CA
94526
|
|
| Correspondent Contact |
DONALD HOLSTEN |
| Date Received | 12/06/1985 |
| Decision Date | 12/24/1985 |
| 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
|
|
|