Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K901130 |
Device Name |
ENTERA-FLO FEEDING TUBE |
Applicant |
FRESENIUS PHARMA |
120 ALBANY STREET, SUITE 700 |
NEW BRUNSWICK,
NJ
08903
|
|
Applicant Contact |
RONALD GUIDO |
Correspondent |
FRESENIUS PHARMA |
120 ALBANY STREET, SUITE 700 |
NEW BRUNSWICK,
NJ
08903
|
|
Correspondent Contact |
RONALD GUIDO |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 03/12/1990 |
Decision Date | 06/01/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|