Device Classification Name |
dialyzer, disposable
|
510(k) Number |
K852764 |
Device Name |
IDECAP DIALYZER |
Applicant |
TRANS-NATIONAL TRADE DEVELOPMENT CORP. |
2 DAG HAMMARSKJOLD PLAZA |
866 SECOND AVENUE |
NEW YORK,
NY
10017
|
|
Applicant Contact |
ROBERT KELLER |
Correspondent |
TRANS-NATIONAL TRADE DEVELOPMENT CORP. |
2 DAG HAMMARSKJOLD PLAZA |
866 SECOND AVENUE |
NEW YORK,
NY
10017
|
|
Correspondent Contact |
ROBERT KELLER |
Regulation Number | 876.5830
|
Classification Product Code |
|
Date Received | 06/28/1985 |
Decision Date | 09/20/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|