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FDA 510(k) Application Details - K062039
Device Classification Name
System, X-Ray, Mammographic
More FDA Info for this Device
510(K) Number
K062039
Device Name
System, X-Ray, Mammographic
Applicant
GIOTTO USA, LLC
11460 N MERIDIAN ST., STE 150
CARMEL, IN 46032 US
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Contact
Allison Scott
Other 510(k) Applications for this Contact
Regulation Number
892.1710
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Classification Product Code
IZH
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More FDA Info for this Product Code
Date Received
07/19/2006
Decision Date
09/11/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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