Device Classification Name |
Dialyzer, Capillary, Hollow Fiber
|
510(k) Number |
K882339 |
Device Name |
BIO*NEPHROSS I.Q. ANDANTE |
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 | 06/06/1988 |
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
|
Recalls |
CDRH Recalls
|
|
|