| 510(k) Number |
K915225 |
| Device Name |
MEGACART |
| Applicant |
| Siemens Burdick, Inc. |
| 15 Plumb St. |
|
Miltoon,
WI
53563
|
|
| Applicant Contact |
FRANCIS I DOMINY |
| Correspondent |
| Siemens Burdick, Inc. |
| 15 Plumb St. |
|
Miltoon,
WI
53563
|
|
| Correspondent Contact |
FRANCIS I DOMINY |
| Classification Product Code |
|
| Date Received | 11/20/1991 |
| Decision Date | 07/01/1992 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|