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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K241055
Device Name Electro Lube NXT
Applicant
Steris
5960 Heisley Rd.
Mento,  OH  44060 -1834
Applicant Contact Steve Elliott
Correspondent
Steris
5960 Heisley Rd.
Mento,  OH  44060 -1834
Correspondent Contact Steven Elliott
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/17/2024
Decision Date 05/31/2024
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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