Device Classification Name |
Endoscopic Access Overtube, Gastroenterology-Urology
|
510(k) Number |
K890629 |
Device Name |
ESOPHAGEAL OVERTUBE |
Applicant |
GASTROTECH, INC. |
6551 BRECKSVILLE RD. |
INDEPENDENCE,
OH
44131
|
|
Applicant Contact |
PAT GILPIN |
Correspondent |
GASTROTECH, INC. |
6551 BRECKSVILLE RD. |
INDEPENDENCE,
OH
44131
|
|
Correspondent Contact |
PAT GILPIN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 02/10/1989 |
Decision Date | 05/31/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|