Device Classification Name |
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
|
510(k) Number |
K982340 |
Device Name |
EXTRACORPOREAL BLOOD CIRCUIT |
Applicant |
HAIDYLENA MEDICAL EGYPT |
26, MAKRAM EBEID ST. |
NASR CITY, CAIRO,
EG
11371
|
|
Applicant Contact |
SAMEH TAMIM |
Correspondent |
HAIDYLENA MEDICAL EGYPT |
26, MAKRAM EBEID ST. |
NASR CITY, CAIRO,
EG
11371
|
|
Correspondent Contact |
SAMEH TAMIM |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 07/06/1998 |
Decision Date | 04/30/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|