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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 K243920
Device Name Purema H Hemoconcentrator - Pediatric
Applicant
Medica USA, Inc.
5610 Rowland Rd.
Suite 145
Minnetonka,  MN  55343
Applicant Contact Greg Collins
Correspondent
Amarex Clinical Research, LLC
20201 Century Blvd., Fourth Floor
Germantown,  MD  20874
Correspondent Contact Ahmad Bayat
Regulation Number876.5860
Classification Product Code
KDI  
Date Received12/20/2024
Decision Date 09/19/2025
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
Predetermined Change
Control Plan Authorized		 No
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