FDA 510(k) Application Details - K182250

Device Classification Name System, Ablation, Microwave And Accessories

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510(K) Number K182250
Device Name System, Ablation, Microwave And Accessories
Applicant AngioDynamics, Inc.
26 Forest St.
Marlborough, MA 01752 US
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Contact Kasey Newcomb
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Regulation Number 878.4400

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Classification Product Code NEY
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Date Received 08/20/2018
Decision Date 02/28/2019
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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