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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 K032633
Device Name HRK-63-8 KNEE ARRAY COIL
Applicant
MRI DEVICES CORP.
1515 PARAMOUNT DR.
WAUKESHA,  WI  53186
Applicant Contact TOM SCHUBERT
Correspondent
MRI DEVICES CORP.
1515 PARAMOUNT DR.
WAUKESHA,  WI  53186
Correspondent Contact TOM SCHUBERT
Regulation Number892.1000
Classification Product Code
MOS  
Date Received08/26/2003
Decision Date 09/25/2003
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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