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FDA 510(k) Application Details - K964069
Device Classification Name
System, X-Ray, Mammographic
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510(K) Number
K964069
Device Name
System, X-Ray, Mammographic
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVE. SOUTH
ISELIN, NJ 08830 US
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Contact
KATHLEEN RUTHERFORD
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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
10/10/1996
Decision Date
05/08/1997
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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