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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
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