Device Classification Name |
endoscopic injection needle, gastroenterology-urology
|
510(k) Number |
K133148 |
Device Name |
BIOMARC COAXIAL NEEDLE |
Applicant |
CARBON MEDICAL TECHNOLOGIES, INC. |
1290 HAMMOND RD. |
ST. PAUL,
MN
55110
|
|
Applicant Contact |
ANDREW J ADAMS |
Correspondent |
CARBON MEDICAL TECHNOLOGIES, INC. |
1290 HAMMOND RD. |
ST. PAUL,
MN
55110
|
|
Correspondent Contact |
ANDREW J ADAMS |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/17/2013 |
Decision Date | 05/13/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|