| Device Classification Name |
First Aid Kit With Drug
|
| 510(k) Number |
K896413 |
| Device Name |
COMBINATION 6X-MAGNIFIER AND TWEEZERS |
| Applicant |
| James Alexander Corp. |
| Rd 3 |
| Box 192 |
|
Blairstown,
NJ
07825
|
|
| Applicant Contact |
DAVID ROBINSON |
| Correspondent |
| James Alexander Corp. |
| Rd 3 |
| Box 192 |
|
Blairstown,
NJ
07825
|
|
| Correspondent Contact |
DAVID ROBINSON |
| Classification Product Code |
|
| Date Received | 11/08/1989 |
| Decision Date | 02/01/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|