Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K160558 |
Device Name |
RAPIDO HOLLOW-FIBRE DIALYZERS |
Applicant |
BELLCO Srl |
via Camurana 1 |
Mirandola,
IT
41037
|
|
Applicant Contact |
Giuseppe Tomasini |
Correspondent |
PAREXEL Consulting, LLC |
195 West Street |
Waltham,
MA
02451
|
|
Correspondent Contact |
Barry Sall |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 02/29/2016 |
Decision Date | 11/18/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|