Device Classification Name |
Tube, Gastro-Enterostomy
|
510(k) Number |
K120587 |
Device Name |
AMT T-FASTENER ANCHOR KIT |
Applicant |
APPLIED MEDICAL TECHNOLOGY, INC. |
8000 KATHERINE BOULEVARD |
BRECKSVILLE,
OH
44141
|
|
Applicant Contact |
ELIZABETH MEYER |
Correspondent |
APPLIED MEDICAL TECHNOLOGY, INC. |
8000 KATHERINE BOULEVARD |
BRECKSVILLE,
OH
44141
|
|
Correspondent Contact |
ELIZABETH MEYER |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 02/27/2012 |
Decision Date | 05/25/2012 |
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
|
|
|