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FDA 510(k) Application Details - K201513
Device Classification Name
More FDA Info for this Device
510(K) Number
K201513
Device Name
Quantra QPlus System
Applicant
HemoSonics, LLC
400 Preston Avenue, Suite 250
Charlottesville, VA 22903 US
Other 510(k) Applications for this Company
Contact
Anne Zavertnik
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QFR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/08/2020
Decision Date
08/21/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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