Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K810996 |
Device Name |
ENTERNAL PUMP SET W/INTEGRAL CONTAINER |
Applicant |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Correspondent |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 04/14/1981 |
Decision Date | 04/29/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|