Device Classification Name |
Biopsy Needle
|
510(k) Number |
K103694 |
Device Name |
TISSUE SAMPLING NEEDLE |
Applicant |
UNITED STATES ENDOSCOPY GROUP, INC. |
5976 HEISLEY RD. |
MENTOR,
OH
44060
|
|
Applicant Contact |
CARROLL L MARTIN |
Correspondent |
UNITED STATES ENDOSCOPY GROUP, INC. |
5976 HEISLEY RD. |
MENTOR,
OH
44060
|
|
Correspondent Contact |
CARROLL L MARTIN |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 12/17/2010 |
Decision Date | 07/27/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|