Device Classification Name |
Colonoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K111028 |
Device Name |
EUS BALLOON |
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 | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/13/2011 |
Decision Date | 11/01/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|