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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, High Permeability With Or Without Sealed Dialysate System
510(k) Number K231406
Device Name ClearumTM HS
Applicant
Bellco Srl
Via Camurana 1
Mirandola,  IT 41037
Applicant Contact Rekha Roveri
Correspondent
Mozarc Medical
710 Medtronic Pkwy. (Lt140)
Minneapolis,  MN  55432
Correspondent Contact Michele Gust
Regulation Number876.5860
Classification Product Code
KDI  
Date Received05/15/2023
Decision Date 06/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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