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FDA 510(k) Application Details - K071787
Device Classification Name
System, X-Ray, Mammographic
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510(K) Number
K071787
Device Name
System, X-Ray, Mammographic
Applicant
DJA DISTRIBUTORS, LLC
2225 E. FLAMINGO ROAD
SUITE 204
LAS VEGAS, NV 89119 US
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Contact
BETH BROMBERG
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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
07/02/2007
Decision Date
10/26/2007
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
Y
Expedited Review
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