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FDA 510(k) Application Details - K023229
Device Classification Name
System, X-Ray, Mammographic
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510(K) Number
K023229
Device Name
System, X-Ray, Mammographic
Applicant
AMERICAN MAMMOGRAPHICS, INC.
1302 SHAWHAN TERRACE
CHATTANOOGA, TN 37411 US
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Contact
ADRIAN PALMER
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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
09/27/2002
Decision Date
12/13/2002
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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