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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
Predetermined Change
Control Plan Authorized		 No
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