| 510(k) Number |
K854281 |
| Device Name |
MAGNETIC RETRIEVER |
| Applicant |
| Aspen Laboratories, Inc. |
| P.O. Box 3936 |
|
Englewood,
CO
80155
|
|
| Applicant Contact |
JOHNSON |
| Correspondent |
| Aspen Laboratories, Inc. |
| P.O. Box 3936 |
|
Englewood,
CO
80155
|
|
| Correspondent Contact |
JOHNSON |
| Date Received | 10/24/1985 |
| Decision Date | 12/02/1985 |
| 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
|
|
|