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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 K890666
Device Name MODEL 3031; CERVICAL SPINE SURFACE COIL
Applicant
Medical Advances, Inc.
10431 W. Watertown Plank Rd.
P.O. Box 26425
Milwaukee,  WI  53226 -0425
Applicant Contact WILLIAM L ZABRISKIE
Correspondent
Medical Advances, Inc.
10431 W. Watertown Plank Rd.
P.O. Box 26425
Milwaukee,  WI  53226 -0425
Correspondent Contact WILLIAM L ZABRISKIE
Regulation Number892.1000
Classification Product Code
LNH  
Date Received02/09/1989
Decision Date 04/14/1989
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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