Device Classification Name |
Clip, Implantable
|
510(k) Number |
K011402 |
Device Name |
BIOPSY SITE MARKER |
Applicant |
SENORX, INC. |
11 COLUMBIA, SUITE A |
ALISO VIEJO,
CA
92656
|
|
Applicant Contact |
AMY BOUCLY |
Correspondent |
SENORX, INC. |
11 COLUMBIA, SUITE A |
ALISO VIEJO,
CA
92656
|
|
Correspondent Contact |
AMY BOUCLY |
Regulation Number | 878.4300
|
Classification Product Code |
|
Date Received | 05/07/2001 |
Decision Date | 07/16/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|