Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22

Dialyzer, High Permeability With Or Without Sealed Dialysate System

Bellco Srl

The following data is part of a premarket notification filed by Bellco Srl with the FDA for Clearum Hs Family, Clearum Hs Models: Hs 13, Hs 15, Hs 17, Hs 20, Hs 22.

Pre-market Notification Details

Device IDK193542
510k NumberK193542
Device Name:Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant Bellco Srl Via Camurana 1 Mirandola,  IT 41037
ContactRekha Roveri
CorrespondentMichele Gust
Medtronic, Inc. 710 Medtronic Parkway (LT140) Minneapolis,  MN  55432
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-20
Decision Date2020-10-08

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.