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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Negative Pressure Wound Therapy Powered Suction Pump
510(k) Number K241515
Device Name NEXA™ NPWT System
Applicant
Nexa Medical Limited
Suite 5-6, Willow View,
Southfields, Church Ln.
Bournemouth,  GB BH22 8TR
Applicant Contact Robbie Walsh
Correspondent
Aoti Limited
Unit 20, Glenrock Business Park
Ballybane
Galway,  IE H91 N23C
Correspondent Contact Robbie Walsh
Regulation Number878.4780
Classification Product Code
OMP  
Date Received05/29/2024
Decision Date 07/26/2024
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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