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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 K901092
Device Name MODEL 8010; EXTREMITY SURFACE COIL
Applicant
Medical Advances, Inc.
10431 W. Watertown Plank Rd.
P.O. Box 26425
Milwaukee,  WI  53226
Applicant Contact L ZABRISKIE
Correspondent
Medical Advances, Inc.
10431 W. Watertown Plank Rd.
P.O. Box 26425
Milwaukee,  WI  53226
Correspondent Contact L ZABRISKIE
Regulation Number892.1000
Classification Product Code
LNH  
Date Received03/07/1990
Decision Date 04/05/1990
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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