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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name system, documentation, breast lesion
De Novo Number DEN020001
510(K) Number K010514
Device Name BREASTVIEW VISUAL MAPPING SYSTEM
Requester
ASSURANCE MEDICAL
555 thirteenth street, n.w.
washington,  DC  20004 -1109
Contact howard m holstein
Regulation Number884.2990
Classification Product Code
NKA  
Date Received05/28/2002
Decision Date 01/31/2003
Decision granted (DENG)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
Type Post-NSE
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