FDA 510(k) Application Details - K221883

Device Classification Name System, Ablation, Microwave And Accessories

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510(K) Number K221883
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
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Regulation Number 878.4400

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Classification Product Code NEY
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Date Received 06/29/2022
Decision Date 03/07/2023
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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