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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 K223856
Device Name NuEra Tight RF Family
Applicant
BIOS s.r.l.
Via Guido Rossa 10/12
Vimodrone,  IT 20055
Applicant Contact Manuela Brambilla
Correspondent
BIOS s.r.l.
Via Guido Rossa 10/12
Vimodrone,  IT 20055
Correspondent Contact Manuela Brambilla
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Codes
NGX   PBX  
Date Received12/23/2022
Decision Date 08/11/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT04406935
Reviewed by Third Party No
Combination Product No
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