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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 K023848
Device Name MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:
Applicant
Igc-Medical Advances, Inc.
10437 Innovation Dr.
Milwaukee,  WI  53226
Applicant Contact R. JERRY FROHLICH
Correspondent
Igc-Medical Advances, Inc.
10437 Innovation Dr.
Milwaukee,  WI  53226
Correspondent Contact R. JERRY FROHLICH
Regulation Number892.1000
Classification Product Code
MOS  
Date Received11/19/2002
Decision Date 02/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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