| 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
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|
| Recalls |
CDRH Recalls
|
|---|