Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K915735 |
Device Name |
FLEXIFLO QUANTUM ENT. PUMP SETS AND ENT. NUT. CONT |
Applicant |
ABBOTT LABORATORIES |
625 CLEVELAND AVE. |
COLUMBUS,
OH
43215
|
|
Applicant Contact |
DANIEL HAMILTON |
Correspondent |
ABBOTT LABORATORIES |
625 CLEVELAND AVE. |
COLUMBUS,
OH
43215
|
|
Correspondent Contact |
DANIEL HAMILTON |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 12/20/1991 |
Decision Date | 06/24/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|