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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K895131
Device Name MODEL 2031 TMJ SURFACE COIL
Applicant
Medical Advances, Inc.
10431 W. Watertown Plank Rd.
P.O. Box 26425
Milwaukee,  WI  53226
Applicant Contact WILLIAM ZABRISKIE
Correspondent
Medical Advances, Inc.
10431 W. Watertown Plank Rd.
P.O. Box 26425
Milwaukee,  WI  53226
Correspondent Contact WILLIAM ZABRISKIE
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/17/1989
Decision Date 10/27/1989
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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