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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 K971668
Device Name SIGNA PROFILE WRIST COIL AND MOBILE SITING OPTIONS
Applicant
GE MEDICAL SYSTEMS
P.O. BOX 414
MILWAUKEE,  WI  53188
Applicant Contact LARRY A KROGER
Correspondent
GE MEDICAL SYSTEMS
P.O. BOX 414
MILWAUKEE,  WI  53188
Correspondent Contact LARRY A KROGER
Regulation Number892.1000
Classification Product Code
LNH  
Date Received05/06/1997
Decision Date 07/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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