| Device Classification Name |
Stopcock, I.V. Set
|
| 510(k) Number |
K010217 |
| Device Name |
4 PORT, 4 WAY STOPCOCK |
| Applicant |
| George Loo, MD |
| 9814 Curwood Pl. |
|
Beverly Hills,
CA
90210
|
|
| Applicant Contact |
GEORGE LOO |
| Correspondent |
| George Loo, MD |
| 9814 Curwood Pl. |
|
Beverly Hills,
CA
90210
|
|
| Correspondent Contact |
GEORGE LOO |
| Regulation Number | 880.5440 |
| Classification Product Code |
|
| Date Received | 01/24/2001 |
| Decision Date | 03/18/2001 |
| 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
|
|
|