| 510(k) Number |
K844596 |
| Device Name |
EMERGENCY ROOM & MINOR OFFICE PROCEDURE CUSTOM KIT |
| Applicant |
| Xanmed Corp. |
| 815 Connecticut Ave. Nw |
|
Washington ,
DC
20006
|
|
| Applicant Contact |
DAVID B VANCE |
| Correspondent |
| Xanmed Corp. |
| 815 Connecticut Ave. Nw |
|
Washington ,
DC
20006
|
|
| Correspondent Contact |
DAVID B VANCE |
| Date Received | 11/26/1984 |
| Decision Date | 08/01/1985 |
| Decision |
Substantially Equivalent - With Drug
(SESD) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|