| Device Classification Name |
Forceps, Biopsy, Non-Electric
|
| 510(k) Number |
K913883 |
| Device Name |
COX DISPOSABLE BIOPSY FORCEP |
| Applicant |
| Cox Medical Ent., Inc. |
| 2186 Eastman Ave., Suite 110 |
|
Ventura,
CA
93003
|
|
| Applicant Contact |
LANITA COX |
| Correspondent |
| Cox Medical Ent., Inc. |
| 2186 Eastman Ave., Suite 110 |
|
Ventura,
CA
93003
|
|
| Correspondent Contact |
LANITA COX |
| Regulation Number | 876.1075 |
| Classification Product Code |
|
| Date Received | 08/29/1991 |
| Decision Date | 10/05/1991 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Gastroenterology/Urology
|
| 510k Review Panel |
Gastroenterology/Urology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|