Device Classification Name |
Marker, Radiographic, Implantable
|
510(k) Number |
K121113 |
Device Name |
BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER |
Applicant |
BIOPSY SCIENCES, LLC |
5582 CHALON RD. |
YORBA LINDA,
FL
33760
|
|
Applicant Contact |
SHARON ROCKWELL |
Correspondent |
BIOPSY SCIENCES, LLC |
5582 CHALON RD. |
YORBA LINDA,
FL
33760
|
|
Correspondent Contact |
SHARON ROCKWELL |
Regulation Number | 878.4300
|
Classification Product Code |
|
Date Received | 04/12/2012 |
Decision Date | 07/12/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|