FDA 510(k) Application Details - K240518

Device Classification Name System, Ablation, Microwave And Accessories

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510(K) Number K240518
Device Name System, Ablation, Microwave And Accessories
Applicant Emblation Limited
Emblation House
Castle Business Park
Stirling FK9 4TS GB
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Contact Mairi MacFadyen
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Regulation Number 878.4400

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Classification Product Code NEY
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Date Received 02/23/2024
Decision Date 04/23/2024
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 K240518


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