Device Classification Name |
marker, radiographic, implantable
|
510(k) Number |
K121964 |
Device Name |
MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML |
Applicant |
AUGMENIX , INC. |
204 SECOND AVENUE |
LOWER LEVEL |
WALTHAM,
MA
02451
|
|
Applicant Contact |
Eric Ankerud |
Correspondent |
AUGMENIX , INC. |
204 SECOND AVENUE |
LOWER LEVEL |
WALTHAM,
MA
02451
|
|
Correspondent Contact |
Eric Ankerud |
Regulation Number | 878.4300
|
Classification Product Code |
|
Date Received | 07/05/2012 |
Decision Date | 01/23/2013 |
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
|