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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 K133821
FOIA Releasable 510(k) K133821
Device Name EMPRINT ABLATION SYSTEM
Applicant
Covidien LLC
15 HAMPSHIRE ST
MANSFIELD,  MA  02048
Applicant Contact HEATHER V NIGRO
Correspondent
Covidien LLC
15 HAMPSHIRE ST
MANSFIELD,  MA  02048
Correspondent Contact HEATHER V NIGRO
Regulation Number878.4400
Classification Product Code
NEY  
Date Received12/16/2013
Decision Date 04/28/2014
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
Recalls CDRH Recalls
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