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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 K031396
Device Name ADVANTAGE WORKSTATION PASTING 1.1
Applicant
GE MEDICAL SYSTEMS
3000 N GRANDVIEW BLVD.
W-400
WAUKESHA,  WI  53188
Applicant Contact LARRY A KROGER
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 COMMERCE RD.
NEWTON,  CT  06470
Correspondent Contact HEINZ-JOERG STENEBERG
Regulation Number892.1000
Classification Product Code
LNH  
Date Received05/02/2003
Decision Date 05/13/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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