Device Classification Name |
Gastroscope And Accessories, Flexible/Rigid
|
510(k) Number |
K130148 |
FOIA Releasable 510(k) |
K130148
|
Device Name |
FOREIGN BODY HOOD |
Applicant |
UNITED STATES ENDOSCOPY GROUP, INC. |
5976 Heisley Rd |
Mentor,
OH
44060
|
|
Applicant Contact |
CARROLL MARTIN |
Correspondent |
UNITED STATES ENDOSCOPY GROUP, INC. |
5976 Heisley Rd |
Mentor,
OH
44060
|
|
Correspondent Contact |
CARROLL MARTIN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 01/22/2013 |
Decision Date | 08/07/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|