| 510(k) Number |
K852095 |
| Device Name |
ESP EMERGENCY CARE KIT |
| Applicant |
| Emergency Situation Products |
| 3240 Aden St. |
|
Memphis,
TN
38127
|
|
| Applicant Contact |
ROBERT T SPALDING |
| Correspondent |
| Emergency Situation Products |
| 3240 Aden St. |
|
Memphis,
TN
38127
|
|
| Correspondent Contact |
ROBERT T SPALDING |
| Date Received | 05/14/1985 |
| Decision Date | 07/11/1985 |
| 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
|
|
|