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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 K240518
Device Name swiftPro™ System
Applicant
Emblation Limited
Emblation House
Castle Business Park
Stirling,  GB FK9 4TS
Applicant Contact Mairi MacFadyen
Correspondent
Blackwell Device Consulting
P.O. Box 718
Gresham,,  OR  97030 -0172
Correspondent Contact Angela Blackwell
Regulation Number878.4400
Classification Product Code
NEY  
Date Received02/23/2024
Decision Date 04/23/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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