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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 K000589
Device Name MODEL 445SI-64E QUADRATURE WRIST COIL
Applicant
IGC-MEDICAL ADVANCES, INC.
10437 INNOVATION DR.
MILWAUKEE,  WI  53226
Applicant Contact THOMAS E TYNES
Correspondent
IGC-MEDICAL ADVANCES, INC.
10437 INNOVATION DR.
MILWAUKEE,  WI  53226
Correspondent Contact THOMAS E TYNES
Regulation Number892.1000
Classification Product Code
MOS  
Date Received02/22/2000
Decision Date 03/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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