| Device Classification Name |
Snare, Flexible
|
| 510(k) Number |
K923671 |
| Device Name |
COX DISPOSABLE POLYPECTOMY SNARES |
| 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 | 876.4300 |
| Classification Product Code |
|
| Date Received | 07/22/1992 |
| Decision Date | 10/13/1992 |
| 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
|
|
|