|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
gambro lundia major high flux hemodialyz
|
GAMBRO, INC.
|
K801480 |
08/27/1980
|
gambro lundia plate high flux hemodial-
|
GAMBRO, INC.
|
K801479 |
08/27/1980
|
gambro lundia plate high flux dialyzer
|
GAMBRO, INC.
|
K811944 |
08/31/1981
|
fh 101, fh 202 & fh 303 fiber hemofilter
|
GAMBRO, INC.
|
K830284 |
03/02/1983
|
ultrafiltration monitor ufm-10-2
|
GAMBRO, INC.
|
K830596 |
04/27/1983
|
hemofiltration system
|
GAMBRO, INC.
|
K831784 |
02/04/1984
|
blood concentrator 140
|
GAMBRO, INC.
|
K840543 |
03/23/1984
|
gambro blood concentrator sets 16,60,200
|
GAMBRO, INC.
|
K854309 |
12/13/1985
|
gambro fiber hemofilters fh 22/66 dispos tube sets
|
GAMBRO, INC.
|
K860938 |
04/07/1986
|
gambro polyflux 130 and 160 hemodialyzer
|
GAMBRO, INC.
|
K871108 |
05/15/1987
|
|