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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 K052045
Device Name ACCESS BREAST COIL
Applicant
Confirma, Inc.
821 Kirkland Ave.
Kirkland,  WA  98033
Applicant Contact PATRICIA A MILBANK
Correspondent
Confirma, Inc.
821 Kirkland Ave.
Kirkland,  WA  98033
Correspondent Contact PATRICIA A MILBANK
Regulation Number892.1000
Classification Product Code
MOS  
Date Received07/28/2005
Decision Date 08/24/2005
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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