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FDA 510(k) Application Details - K191495
Device Classification Name
System, X-Ray, Mammographic
More FDA Info for this Device
510(K) Number
K191495
Device Name
System, X-Ray, Mammographic
Applicant
FUJIFILM Corporation
798 Miyanodai Kaisei-Machi
Ashigarakami-Gun JP
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Contact
Randy Vader
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
06/05/2019
Decision Date
07/03/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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