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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 K123708
Device Name SPINE COIL
Applicant
Usa Paramed Medical Systems, Inc.
6204 W. Oakton St.
Morton Grove,  IL  60053
Applicant Contact RICHARD OLSON
Correspondent
Usa Paramed Medical Systems, Inc.
6204 W. Oakton St.
Morton Grove,  IL  60053
Correspondent Contact RICHARD OLSON
Regulation Number892.1000
Classification Product Code
MOS  
Date Received12/03/2012
Decision Date 04/10/2013
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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