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FDA 510(k) Application Details - K230461
Device Classification Name
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510(K) Number
K230461
Device Name
Quantra Hemostasis Analyzer
Applicant
HemoSonics, LLC
4020 Stirrup Creek Drive, Suite 105
Durham, NC 27703 US
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Contact
Debbie Winegar
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Regulation Number
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Classification Product Code
QFR
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Date Received
02/21/2023
Decision Date
03/24/2023
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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