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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 K003144
Device Name MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL
Applicant
MEDICAL ADVANCES, INC.
10437 INNOVATION DR.
MILWAUKEE,  WI  53226
Applicant Contact THOMAS E TYNES
Correspondent
MEDICAL ADVANCES, INC.
10437 INNOVATION DR.
MILWAUKEE,  WI  53226
Correspondent Contact THOMAS E TYNES
Regulation Number892.1000
Classification Product Code
MOS  
Date Received10/10/2000
Decision Date 12/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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