| Device Classification Name |
Motor, Surgical Instrument, Ac-Powered
|
| 510(k) Number |
K850389 |
| Device Name |
MULTIPLE OUTLET MANIFOLD |
| Applicant |
| The Anspach Effort, Inc. |
| 1349 S. Killian Dr. |
|
Lake Park,
FL
33403
|
|
| Applicant Contact |
ANSPACH |
| Correspondent |
| The Anspach Effort, Inc. |
| 1349 S. Killian Dr. |
|
Lake Park,
FL
33403
|
|
| Correspondent Contact |
ANSPACH |
| Regulation Number | 878.4820 |
| Classification Product Code |
|
| Date Received | 02/01/1985 |
| Decision Date | 03/18/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|