| Device Classification Name |
Device, Intravascular Catheter Securement
|
| 510(k) Number |
K932757 |
| Device Name |
SECURODRIP (TM) I.V. ARMBOARD |
| Applicant |
| Op-Co Medical Products , Ltd. |
| 30 Rockefeller Plz. |
| Rm. 5455 |
|
New York City,
NY
10112
|
|
| Applicant Contact |
JANICE COOK |
| Correspondent |
| Op-Co Medical Products , Ltd. |
| 30 Rockefeller Plz. |
| Rm. 5455 |
|
New York City,
NY
10112
|
|
| Correspondent Contact |
JANICE COOK |
| Regulation Number | 880.5210 |
| Classification Product Code |
|
| Date Received | 06/04/1993 |
| Decision Date | 12/08/1993 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|