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FDA 510(k) Application Details - K173132
Device Classification Name
Full Field Digital,System,X-Ray,Mammographic
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510(K) Number
K173132
Device Name
Full Field Digital,System,X-Ray,Mammographic
Applicant
Fujifilm Medical Systems U.S.A., Inc.
419 West Avenue
Stamford, CT 06902 US
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Contact
Jyh-Shyan Lin
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Regulation Number
000.0000
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Classification Product Code
MUE
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More FDA Info for this Product Code
Date Received
09/29/2017
Decision Date
10/27/2017
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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