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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K102771
Device Name BIOPSY HANDY, MRI BIOPSY HANDY
Applicant
Somatex Medical Technologies GmbH
1480 Cambridge St.
Cambridge,  MA  02139
Applicant Contact SUSANNE RAAB
Correspondent
Somatex Medical Technologies GmbH
1480 Cambridge St.
Cambridge,  MA  02139
Correspondent Contact SUSANNE RAAB
Regulation Number876.1075
Classification Product Code
KNW  
Date Received09/24/2010
Decision Date 06/24/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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