Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K890151 |
Device Name |
ENTERAL BAG/SET |
Applicant |
ASHLEY HEALTH CARE, INC. |
P.O. BOX 1106 |
DOYLESTOWN,
PA
18901
|
|
Applicant Contact |
SCOTT A COLLINS |
Correspondent |
ASHLEY HEALTH CARE, INC. |
P.O. BOX 1106 |
DOYLESTOWN,
PA
18901
|
|
Correspondent Contact |
SCOTT A COLLINS |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 01/13/1989 |
Decision Date | 05/23/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|