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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K140252
Device Name 16 CH MULTIPURPOSE COIL VARIETY
Applicant
Noras Rontgen-Und Medizintechnik GmbH
Leibnizstrasse 4
Höchberg,  DE 97204
Applicant Contact ZAHED SEDIGHIANI
Correspondent
Noras Rontgen-Und Medizintechnik GmbH
Leibnizstrasse 4
Höchberg,  DE 97204
Correspondent Contact ZAHED SEDIGHIANI
Regulation Number892.1000
Classification Product Code
MOS  
Date Received01/31/2014
Decision Date 05/08/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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