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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Ablation, Microwave And Accessories
510(k) Number K250718
Device Name swiftPro System (SWF-SPS); Swift System (SWF-SYS)
Applicant
Emblation Limited
Emblation House
Castle Business Park
Stirling,  GB FK9 4TS
Applicant Contact Jack Ozer
Correspondent
Blackwell Device Consulting
P.O. Box 718
Gresham,  OR  97030
Correspondent Contact Angela Blackwell
Regulation Number878.4400
Classification Product Code
NEY  
Date Received03/10/2025
Decision Date 08/08/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT05371834
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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