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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 K153599
Device Name Concert Medical Hands-Free Syringe (HFS)
Applicant
Concert Medical, LLC
77 Accord Park Dr.
Norwell,  MA  02061
Applicant Contact Timothy S Powers
Correspondent
Delphi Medical Device Consulting, Inc.
5 Whitcomb Ave.
Ayer,  MA  01432
Correspondent Contact Pamela Papineau
Regulation Number880.5725
Classification Product Code
FRN  
Date Received12/16/2015
Decision Date 09/01/2016
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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