Device Classification Name |
marker, radiographic, implantable
|
510(k) Number |
K123911 |
Device Name |
SENOMARK ULTRA BREAST TISSUE MARKER |
Applicant |
C.R. BARD, INC. |
1625 WEST 3RD ST. |
TEMPE,
AZ
85281 -1740
|
|
Applicant Contact |
SARAH MCCARTNEY |
Correspondent |
C.R. BARD, INC. |
1625 WEST 3RD ST. |
TEMPE,
AZ
85281 -1740
|
|
Correspondent Contact |
SARAH MCCARTNEY |
Regulation Number | 878.4300
|
Classification Product Code |
|
Date Received | 12/19/2012 |
Decision Date | 01/10/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|