FDA 510(k) Application Details - K203303

Device Classification Name System, Ablation, Microwave And Accessories

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510(K) Number K203303
Device Name System, Ablation, Microwave And Accessories
Applicant Covidien, LLC
5920 Longbow Dr
Boulder, CO 80301 US
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Contact Liron Bar-Yaakov
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Regulation Number 878.4400

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Classification Product Code NEY
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Date Received 11/09/2020
Decision Date 12/17/2020
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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