| Device Classification Name |
First Aid Kit With Drug
|
| 510(k) Number |
K903393 |
| Device Name |
AUTO FIRST-AID KIT FOR AMERICA |
| Applicant |
| Hisler-Radke, Inc. |
| 2355 Red Rock |
| Suite 106 |
|
Las Vegas,
NV
89102
|
|
| Applicant Contact |
DAN RADKE |
| Correspondent |
| Hisler-Radke, Inc. |
| 2355 Red Rock |
| Suite 106 |
|
Las Vegas,
NV
89102
|
|
| Correspondent Contact |
DAN RADKE |
| Classification Product Code |
|
| Date Received | 07/27/1990 |
| Decision Date | 01/31/1991 |
| Decision |
Substantially Equivalent - Kit
(SESK) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|