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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 K052585
Device Name 3T HD BREAST ARRAY
Applicant
Usa Instruments, Inc.
1515 Danner Dr.
Aurora,  OH  44202
Applicant Contact DAVID BROWN
Correspondent
Usa Instruments, Inc.
1515 Danner Dr.
Aurora,  OH  44202
Correspondent Contact DAVID BROWN
Regulation Number892.1000
Classification Product Code
MOS  
Date Received09/20/2005
Decision Date 10/04/2005
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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