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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 K093348
Device Name 3.0T 16 CHANNEL HEAD NECK SPINE COIL
Applicant
Ge Healthcare Coils (Usa Instruments, Inc.)
3200 N Grandview Blvd., Mail
Code : W-827
Waukesha,  WI  53188 -9273
Applicant Contact ELIZABETH MATHEW
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL LEHTONEN
Regulation Number892.1000
Classification Product Code
MOS  
Date Received10/27/2009
Decision Date 11/25/2009
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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