Device Classification Name |
dialyzer, capillary, hollow fiber
|
510(k) Number |
K882215 |
Device Name |
NEPHROSS I.Q. MODERATO |
Applicant |
ORGANON TEKNIKA CORP. |
800 CAPITOLA DR. |
DURHAM,
NC
27713
|
|
Applicant Contact |
SHELDON MAZURSKY |
Correspondent |
ORGANON TEKNIKA CORP. |
800 CAPITOLA DR. |
DURHAM,
NC
27713
|
|
Correspondent Contact |
SHELDON MAZURSKY |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 05/26/1988 |
Decision Date | 06/28/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|