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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, nuclear magnetic resonance imaging
510(k) Number K884484
Device Name MAGNETIC RESONANCE DIAGNOSTIC HELMHOLTZ NECK COIL
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVENUE SOUTH
ISELIN,  NJ  08830
Applicant Contact SCOTT A HENSLEY
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVENUE SOUTH
ISELIN,  NJ  08830
Correspondent Contact SCOTT A HENSLEY
Regulation Number892.1000
Classification Product Code
LNH  
Date Received10/25/1988
Decision Date 01/17/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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