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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 K930045
Device Name MODEL #QSC-200-21 20 CM. QUADRATURE SHOULDER COIL
Applicant
MRI DEVICES CORP.
1900 PEWAUKEE ROAD, SUITE N
AIRPORT BUSINESS CENTER
WAUKESHA,  WI  53188
Applicant Contact THOMAS SCHUBERT
Correspondent
MRI DEVICES CORP.
1900 PEWAUKEE ROAD, SUITE N
AIRPORT BUSINESS CENTER
WAUKESHA,  WI  53188
Correspondent Contact THOMAS SCHUBERT
Regulation Number892.1000
Classification Product Code
LNH  
Date Received01/05/1993
Decision Date 07/26/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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