Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K073034 |
Device Name |
AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419) |
Applicant |
APPLIED MEDICAL TECHNOLOGY, INC. |
15653 NEO PKWY. |
CLEVELAND,
OH
44128
|
|
Applicant Contact |
BRIAN BAKER |
Correspondent |
APPLIED MEDICAL TECHNOLOGY, INC. |
15653 NEO PKWY. |
CLEVELAND,
OH
44128
|
|
Correspondent Contact |
BRIAN BAKER |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 10/26/2007 |
Decision Date | 03/14/2008 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|