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FDA 510(k) Application Details - K193166
Device Classification Name
Full Field Digital,System,X-Ray,Mammographic
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510(K) Number
K193166
Device Name
Full Field Digital,System,X-Ray,Mammographic
Applicant
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard, 65-1A
Malvern, PA 19355 US
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Contact
Martin Rajchel
Other 510(k) Applications for this Contact
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
11/15/2019
Decision Date
06/12/2020
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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