| 510(k) Number |
K901374 |
| Device Name |
CENTREMARK(TM) CENTRAL VENOUS CATHETER TRAY |
| Applicant |
| Menlo Care, Inc. |
| 1053 E. Meadow Circle |
|
Palo Alto,
CA
94303
|
|
| Applicant Contact |
J. M WALKER |
| Correspondent |
| Menlo Care, Inc. |
| 1053 E. Meadow Circle |
|
Palo Alto,
CA
94303
|
|
| Correspondent Contact |
J. M WALKER |
| Date Received | 03/22/1990 |
| Decision Date | 06/26/1990 |
| Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|