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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K183311
Device Name Ivenix Infusion System (IIS)
Applicant
Ivenix, Inc.
50 High St., Suite 50
North Andover,  MA  01845
Applicant Contact John J. Sokolowski
Correspondent
Ivenix, Inc.
50 High St., Suite 50
North Andover,  MA  01845
Correspondent Contact John J. Sokolowski
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Codes
FPA   PHC  
Date Received11/29/2018
Decision Date 06/07/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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