| Device Classification Name |
Stand, Infusion
|
| 510(k) Number |
K870473 |
| Device Name |
STAT-STAND(TM) AND STAT-STAND II(TM) |
| Applicant |
| I.V. League Medical |
| P.O. Box 341 |
|
Newbury Park,
CA
91320
|
|
| Applicant Contact |
TED ISENBURG |
| Correspondent |
| I.V. League Medical |
| P.O. Box 341 |
|
Newbury Park,
CA
91320
|
|
| Correspondent Contact |
TED ISENBURG |
| Regulation Number | 880.6990 |
| Classification Product Code |
|
| Date Received | 02/03/1987 |
| Decision Date | 02/13/1987 |
| 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
|
|
|