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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 K021433
Device Name MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL
Applicant
Medical Advances, Inc.
10437 Innovation Dr.
Milwaukee,  WI  53226
Applicant Contact JERRY FROHLICH
Correspondent
Medical Advances, Inc.
10437 Innovation Dr.
Milwaukee,  WI  53226
Correspondent Contact JERRY FROHLICH
Regulation Number892.1000
Classification Product Code
MOS  
Date Received05/06/2002
Decision Date 06/13/2002
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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