Device Classification Name |
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
|
510(k) Number |
K864784 |
Device Name |
SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS |
Applicant |
CD MEDICAL, INC. |
14620 N.W. 60TH AVE. |
MIAMI LAKES,
FL
33014
|
|
Applicant Contact |
JARVIS, PH.D. |
Correspondent |
CD MEDICAL, INC. |
14620 N.W. 60TH AVE. |
MIAMI LAKES,
FL
33014
|
|
Correspondent Contact |
JARVIS, PH.D. |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 12/08/1986 |
Decision Date | 01/20/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|