| Device Classification Name |
Prosthesis, Vas Deferens
|
| 510(k) Number |
K851719 |
| Device Name |
1070/15 TO 1078/17 VARIOUS TYPES NEEDLE HOLDERS |
| Applicant |
| Artiberia |
| 4518 Los Ranchitos |
|
San Antonio,
TX
78233
|
|
| Applicant Contact |
GIL M SANCHEZ |
| Correspondent |
| Artiberia |
| 4518 Los Ranchitos |
|
San Antonio,
TX
78233
|
|
| Correspondent Contact |
GIL M SANCHEZ |
| Classification Product Code |
|
| Date Received | 04/25/1985 |
| Decision Date | 07/02/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Gastroenterology/Urology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|