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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 K160594
Device Name MRWire Guide Wire
Applicant
Nano4imaging GmbH
Pauwelsstr. 17
Aachen,  DE 52074
Applicant Contact CHRISTOPH R. MANEGOLD
Correspondent
Turnstone Alliance Group, LLC
45 Rockefeller Plz., Suite 2000
New York,  NY  10111
Correspondent Contact JUDITH HARRINGTON
Regulation Number870.1330
Classification Product Code
DQX  
Date Received03/01/2016
Decision Date 11/22/2016
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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