Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K900918 |
Device Name |
GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER |
Applicant |
GAMBRO, INC. |
460 MCLAWS CIRCLE, SUITE 200 |
WILLIAMSBURG,
VA
23185
|
|
Applicant Contact |
JEFFREY R SHIDEMAN |
Correspondent |
GAMBRO, INC. |
460 MCLAWS CIRCLE, SUITE 200 |
WILLIAMSBURG,
VA
23185
|
|
Correspondent Contact |
JEFFREY R SHIDEMAN |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 02/27/1990 |
Decision Date | 07/16/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|