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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 K072909
Device Name 1.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL
Applicant
SIEMENS AG, MEDICAL SOLUTIONS
HENKESTRASSE 127
ERLANGEN,  DE 91052
Applicant Contact LUTZ MAHN
Correspondent
TUV SUD AMERICA INC.
1775 OLD HIGHWAY 8 NW
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number892.1000
Classification Product Code
MOS  
Date Received10/12/2007
Decision Date 10/31/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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