| Device Classification Name |
Snare, Flexible
|
| 510(k) Number |
K902265 |
| Device Name |
FLEXIBLE SNARE |
| Applicant |
| Annex Medical, Inc. |
| 7887 Fuller Rd. #109 |
|
Eden Prairie,
MN
55344
|
|
| Applicant Contact |
STUART J LIND |
| Correspondent |
| Annex Medical, Inc. |
| 7887 Fuller Rd. #109 |
|
Eden Prairie,
MN
55344
|
|
| Correspondent Contact |
STUART J LIND |
| Regulation Number | 876.4300 |
| Classification Product Code |
|
| Date Received | 05/21/1990 |
| Decision Date | 07/27/1990 |
| 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
|
|
|