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FDA 510(k) Application Details - K213067
Device Classification Name
System, Ablation, Microwave And Accessories
More FDA Info for this Device
510(K) Number
K213067
Device Name
System, Ablation, Microwave And Accessories
Applicant
AngioDynamics, Inc.
26 Forest Street
Marlborough, MA 01752 US
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Contact
Kasey E Newcomb
Other 510(k) Applications for this Contact
Regulation Number
878.4400
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Classification Product Code
NEY
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More FDA Info for this Product Code
Date Received
09/23/2021
Decision Date
12/03/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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