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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 K214045
Device Name FreedomEdge Syringe Infusion System
Applicant
Repro-Medical System, Inc., Dba Koru Medical Systems
24 Carpenter Rd.
New York,  NY  10918
Applicant Contact Christopher Pazdan
Correspondent
510K Technology Group, LLC
17 Orchard Terrace
East Arlington,  MA  02474
Correspondent Contact Kachi Enyinna
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Codes
FPA   PKP  
Date Received12/27/2021
Decision Date 04/29/2022
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
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