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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 K993776
Device Name OBC-300 BREAST ARRAY COIL
Applicant
MRI DEVICES CORP.
N8 W22520 JOHNSON DR., UNIT K
JOHNSON DR., CORPORATE CENTER
WAUKESHA,  WI  53186
Applicant Contact THOMAS SCHUBERT
Correspondent
MRI DEVICES CORP.
N8 W22520 JOHNSON DR., UNIT K
JOHNSON DR., CORPORATE CENTER
WAUKESHA,  WI  53186
Correspondent Contact THOMAS SCHUBERT
Regulation Number892.1000
Classification Product Code
MOS  
Date Received11/08/1999
Decision Date 12/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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