Device Classification Name |
Staple, Implantable
|
510(k) Number |
K032347 |
Device Name |
BIOMARC TISSUE MARKER |
Applicant |
CARBON MEDICAL TECHNOLOGIES, INC. |
1290 HAMMOND RD. |
ST. PAUL,
MN
55110
|
|
Applicant Contact |
ROBERT W JOHNSON |
Correspondent |
CARBON MEDICAL TECHNOLOGIES, INC. |
1290 HAMMOND RD. |
ST. PAUL,
MN
55110
|
|
Correspondent Contact |
ROBERT W JOHNSON |
Regulation Number | 878.4750
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/30/2003 |
Decision Date | 08/21/2003 |
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
|
|
|