Device Classification Name |
dialyzer, capillary, hollow fiber
|
510(k) Number |
K892523 |
Device Name |
GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY |
Applicant |
GAMBRO, INC. |
460 MCLAWS CIRCLE, SUITE 200 |
WILLIAMSBURG,
VA
23185
|
|
Applicant Contact |
JEFFREY SHIDEMAN |
Correspondent |
GAMBRO, INC. |
460 MCLAWS CIRCLE, SUITE 200 |
WILLIAMSBURG,
VA
23185
|
|
Correspondent Contact |
JEFFREY SHIDEMAN |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 04/11/1989 |
Decision Date | 05/11/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|