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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
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