| Device Classification Name |
First Aid Kit With Drug
|
| 510(k) Number |
K921762 |
| Device Name |
SHAWNEE PRODUCTS KIT I |
| Applicant |
| Absentee Shawnee Bandage Group |
| 1201 Holly Ln. |
|
Tecumseh,
OK
74873
|
|
| Applicant Contact |
EARL LITTLE |
| Correspondent |
| Absentee Shawnee Bandage Group |
| 1201 Holly Ln. |
|
Tecumseh,
OK
74873
|
|
| Correspondent Contact |
EARL LITTLE |
| Classification Product Code |
|
| Date Received | 04/14/1992 |
| Decision Date | 01/06/1993 |
| Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|