Device Classification Name |
enteral specific transition connectors
|
510(k) Number |
K150034 |
Device Name |
AMT Enteral Transition Adapters |
Applicant |
APPLIED MEDICAL TECHNOLOGY, INC. |
8006 KATHERINE BOULEVARD |
BRECKSVILLE,
OH
44141
|
|
Applicant Contact |
JOSHUA MEINKE |
Correspondent |
APPLIED MEDICAL TECHNOLOGY, INC. |
8006 KATHERINE BOULEVARD |
BRECKSVILLE,
OH
44141
|
|
Correspondent Contact |
JOSHUA MEINKE |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 01/09/2015 |
Decision Date | 06/09/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|