FDA 510(k) Application Details - K233838

Device Classification Name System, Ablation, Microwave And Accessories

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510(K) Number K233838
Device Name System, Ablation, Microwave And Accessories
Applicant Medtronic, Inc
200 Medtronic Dr
Lafayette, CO 80026 US
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Contact Steve Pavlik
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Regulation Number 878.4400

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Classification Product Code NEY
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Date Received 12/04/2023
Decision Date 03/28/2024
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

FDA Source Information for K233838


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