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FDA 510(k) Application Details - DEN020001
Device Classification Name
System, Documentation, Breast Lesion
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510(K) Number
DEN020001
Device Name
System, Documentation, Breast Lesion
Applicant
ASSURANCE MEDICAL
555 THIRTEENTH STREET, N.W.
WASHINGTON, DC 20004-1109 US
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Contact
HOWARD M HOLSTEIN
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Regulation Number
884.2990
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Classification Product Code
NKA
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More FDA Info for this Product Code
Date Received
05/28/2002
Decision Date
01/31/2003
Decision
DENG -
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Type
Post-NSE
Reviewed By Third Party
N
Expedited Review
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