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FDA 510(k) Application Details - K210054
Device Classification Name
More FDA Info for this Device
510(K) Number
K210054
Device Name
Cios Spin
Applicant
Siemens Medical Systems USA, Inc.
40 Liberty Boulevard, 65-1A
Malvern, PA 19355 US
Other 510(k) Applications for this Company
Contact
Cordell Fields
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Regulation Number
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Classification Product Code
OWB
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More FDA Info for this Product Code
Date Received
01/08/2021
Decision Date
02/05/2021
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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