Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K980386 |
Device Name |
HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0) |
Applicant |
GAMBRO HEALTHCARE |
1185 OAK ST. |
LAKEWOOD,
CO
80215 -4498
|
|
Applicant Contact |
JEFFREY R SHIDEMAN |
Correspondent |
GAMBRO HEALTHCARE |
1185 OAK ST. |
LAKEWOOD,
CO
80215 -4498
|
|
Correspondent Contact |
JEFFREY R SHIDEMAN |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 02/02/1998 |
Decision Date | 02/24/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|