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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K242132
Device Name FREDDO
Applicant
Fabinject Lndustria E Comercio Lmportacao E Exportacao Ltda
Rua Engenheiro Joao Porfirio De Macedo 401
Taubate,  BR 12072-270
Applicant Contact Gianmaria Cominato Filho
Correspondent
Regulab
34 Pinar Del Rio Ave.
Brownsville,  TX  78526
Correspondent Contact Aleksandro Garrido Gardano
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/22/2024
Decision Date 10/18/2024
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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