| Device Classification Name |
Set, Administration, Intravascular
|
| 510(k) Number |
K913076 |
| Device Name |
I.V. INSTANT TIMER |
| Applicant |
| The Master Medical Corp. |
| C/O Mckenna & Cuneo Law Office |
| 1575 Eye St., NW |
|
Washington,
DC
20005
|
|
| Applicant Contact |
DONALD R STONE |
| Correspondent |
| The Master Medical Corp. |
| C/O Mckenna & Cuneo Law Office |
| 1575 Eye St., NW |
|
Washington,
DC
20005
|
|
| Correspondent Contact |
DONALD R STONE |
| Regulation Number | 880.5440 |
| Classification Product Code |
|
| Date Received | 07/11/1991 |
| Decision Date | 10/17/1991 |
| 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
|
|
|