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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
Original Applicant
USA INSTRUMENTS, INC.
1515 danner dr.
aurora,  OH  44202
Original 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
Recalls CDRH Recalls
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