Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K994198 |
Device Name |
HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L |
Applicant |
TORAY INDUSTRIES (AMERICA), INC. |
540 COLLEGE ST. |
BELLAIRE,
TX
77401 -5010
|
|
Applicant Contact |
LISA S JONES |
Correspondent |
TORAY INDUSTRIES (AMERICA), INC. |
540 COLLEGE ST. |
BELLAIRE,
TX
77401 -5010
|
|
Correspondent Contact |
LISA S JONES |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 12/13/1999 |
Decision Date | 08/25/2000 |
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
|
|
|