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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 K181941
Device Name Swift System
Applicant
Emblation , Ltd.
Forrester Lodge
Alloa,  GB FK10 2HU
Applicant Contact Mairi MacFadyen
Correspondent
Emblation , Ltd.
Forrester Lodge
Alloa,  GB FK10 2HU
Correspondent Contact Mairi MacFadyen
Regulation Number878.4400
Classification Product Code
NEY  
Date Received07/20/2018
Decision Date 10/18/2018
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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