Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K911094 |
Device Name |
INPERSOL CAPD BIOCAP ADMINISTRATION SET |
Applicant |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Applicant Contact |
FREDERICK GUSTAFSON |
Correspondent |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Correspondent Contact |
FREDERICK GUSTAFSON |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 03/13/1991 |
Decision Date | 04/16/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|