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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 K964969
Device Name SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3)
Applicant
GE Medical Systems
3200 N Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact LARRY A KROGER, PH.D.
Correspondent
GE Medical Systems
3200 N Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact LARRY A KROGER, PH.D.
Regulation Number892.1000
Classification Product Code
MOS  
Date Received12/12/1996
Decision Date 06/26/1997
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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