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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 K041695
Device Name LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE
Applicant
Usa Instruments, Inc.
1515 Danner Dr.
Aurora,  OH  44202
Applicant Contact JAMES WRENN
Correspondent
Usa Instruments, Inc.
1515 Danner Dr.
Aurora,  OH  44202
Correspondent Contact JAMES WRENN
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/22/2004
Decision Date 07/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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