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FDA 510(k) Application Details - K202347
Device Classification Name
More FDA Info for this Device
510(K) Number
K202347
Device Name
UNIFUSE Infusion System with Cooper Wire
Applicant
AngioDynamics, Inc.
26 Forest Street, Suite 200
Marlborough, MA 01752 US
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Contact
Brandon M. Brackett
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Regulation Number
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Classification Product Code
QEY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/18/2020
Decision Date
09/15/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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