Device Classification Name |
Dialyzer, Capillary, Hollow Fiber
|
510(k) Number |
K973291 |
Device Name |
DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES |
Applicant |
DYNAMIC TECHNOLOGY CORP. |
6833 SAINT LAWRENCE ST. |
PLANO,
TX
75024
|
|
Applicant Contact |
ERIC LUO |
Correspondent |
DYNAMIC TECHNOLOGY CORP. |
6833 SAINT LAWRENCE ST. |
PLANO,
TX
75024
|
|
Correspondent Contact |
ERIC LUO |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 09/02/1997 |
Decision Date | 12/19/1997 |
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
|
|
|