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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 K020850
Device Name GPF-29 GENERAL PURPOSE COIL SET
Applicant
MRI DEVICES CORP.
1515 PARAMOUNT DR.
WAUKESHA,  WI  53186
Applicant Contact DAVID A MOLYNEAUX
Correspondent
MRI DEVICES CORP.
1515 PARAMOUNT DR.
WAUKESHA,  WI  53186
Correspondent Contact DAVID A MOLYNEAUX
Regulation Number892.1000
Classification Product Code
MOS  
Date Received03/15/2002
Decision Date 06/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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