Device Classification Name |
Biopsy Needle
|
510(k) Number |
K133763 |
Device Name |
SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM |
Applicant |
MEDI-GLOBE CORPORATION |
110 WEST ORION STREET |
TEMPE,
AZ
85283
|
|
Applicant Contact |
SCOTT KARLER |
Correspondent |
MEDI-GLOBE CORPORATION |
110 WEST ORION STREET |
TEMPE,
AZ
85283
|
|
Correspondent Contact |
SCOTT KARLER |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 12/11/2013 |
Decision Date | 05/15/2014 |
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
|
|
|