FDA 510(k) Application Details - K162449

Device Classification Name System, Ablation, Microwave And Accessories

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510(K) Number K162449
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 09/01/2016
Decision Date 05/05/2017
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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