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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K153397
Device Name S-Wire Guidewire System
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 Number870.1330
Classification Product Code
DQX  
Date Received11/24/2015
Decision Date 08/18/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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