Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K112863 |
Device Name |
ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION SET, ENTERAL EXTENSION SET WITH MINITUBE CONN |
Applicant |
ACTA MEDICAL L.L.C. |
929 ARBOR DOWNS DRIVE |
PLANO,
TX
75023
|
|
Applicant Contact |
AARON COMPTON |
Correspondent |
ACTA MEDICAL L.L.C. |
929 ARBOR DOWNS DRIVE |
PLANO,
TX
75023
|
|
Correspondent Contact |
AARON COMPTON |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 09/30/2011 |
Decision Date | 03/29/2012 |
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
|
|
|