| 510(k) Number |
K863162 |
| Device Name |
VACU-GUARD |
| Applicant |
| Arbor Technologies, Inc. |
| 3728-1 Plz. Dr. |
|
Ann Arbor,
MI
48104
|
|
| Applicant Contact |
DAWN I MOORE |
| Correspondent |
| Arbor Technologies, Inc. |
| 3728-1 Plz. Dr. |
|
Ann Arbor,
MI
48104
|
|
| Correspondent Contact |
DAWN I MOORE |
| Date Received | 08/18/1986 |
| Decision Date | 08/29/1986 |
| 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
|
|
|