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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 K991434
Device Name QUADRATURE WRIST COIL, MODEL 445PH-64
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 Received04/26/1999
Decision Date 07/06/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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