FDA 510(k) Application Details - K241827

Device Classification Name System, Ablation, Microwave And Accessories

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510(K) Number K241827
Device Name System, Ablation, Microwave And Accessories
Applicant Canyon Medical Inc.
Building 3, Phase 2 Accelerator, No. 11 Yaogu Avenue
Jiangbei New Area
Nanjing 210032 CN
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Contact Huiqi Jiang
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Regulation Number 878.4400

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Classification Product Code NEY
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Date Received 06/24/2024
Decision Date 09/26/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K241827


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