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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 K230632
FOIA Releasable 510(k) K230632
Device Name VersiHD with GuideMe software
Applicant
Nxstage Medical, Inc.
350 Merrimack St.
Lawrence,  MA  01843
Applicant Contact Denise Oppermann
Correspondent
Nxstage Medical, Inc.
350 Merrimack St.
Lawrence,  MA  01843
Correspondent Contact Denise Oppermann
Regulation Number876.5860
Classification Product Code
KDI  
Date Received03/07/2023
Decision Date 08/11/2023
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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