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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 K003340
Device Name OBC-149 BREAST ARRAY COIL
Applicant
MRI DEVICES CORP.
1515 PARAMOUNT DR.
WAUKESHA,  WI  53186
Applicant Contact THOMAS SCHUBERT
Correspondent
MRI DEVICES CORP.
1515 PARAMOUNT DR.
WAUKESHA,  WI  53186
Correspondent Contact THOMAS SCHUBERT
Regulation Number892.1000
Classification Product Code
MOS  
Date Received10/25/2000
Decision Date 11/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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