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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 K052987
Device Name BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC
Applicant
NORAS RONTGEN-UND MEDIZINTECHNIK GMBH
1600 MANCHESTER WAY
CORINTH,  TX  76210
Applicant Contact CARL ALLETTO
Correspondent
NORAS RONTGEN-UND MEDIZINTECHNIK GMBH
1600 MANCHESTER WAY
CORINTH,  TX  76210
Correspondent Contact CARL ALLETTO
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
MOS  
Date Received10/24/2005
Decision Date 11/08/2005
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
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