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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 K950837
Device Name AURORA IMAGING SYSTEM
Applicant
Advanced Mammography Systems, Inc.
46 Jonspin Rd.
Wilmington,  MA  01887
Applicant Contact MICHAEL L KRACHON
Correspondent
Advanced Mammography Systems, Inc.
46 Jonspin Rd.
Wilmington,  MA  01887
Correspondent Contact MICHAEL L KRACHON
Regulation Number892.1000
Classification Product Code
LNH  
Date Received02/24/1995
Decision Date 02/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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