Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K895366 |
Device Name |
ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE |
Applicant |
FRESENIUS USA, INC. |
120 ALBANY ST. |
P.O. BOX 2623 |
NEW BRUNSWICK,
NJ
08903
|
|
Applicant Contact |
MICHELE DZIEDZIC |
Correspondent |
FRESENIUS USA, INC. |
120 ALBANY ST. |
P.O. BOX 2623 |
NEW BRUNSWICK,
NJ
08903
|
|
Correspondent Contact |
MICHELE DZIEDZIC |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 08/28/1989 |
Decision Date | 05/02/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|