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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 K162613
Device Name Integrated Catch-up Freedom Syringe Driver Infusion System
Applicant
Repro-Med Systems, Inc. Dba Rms Medical Products
24 Carpenter Rd.
New York,  NY  10918
Applicant Contact Fred Ma
Correspondent
Repro-Med Systems, Inc. Dba Rms Medical Products
24 Carpenter Rd.
New York,  NY  10918
Correspondent Contact Fred Ma
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Codes
FPA   PKP  
Date Received09/19/2016
Decision Date 08/31/2017
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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