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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene
510(k) Number K253910
Device Name Stitch - Suture Wires and Tapes
Applicant
GM Dos Reis Industria e Comercio Ltda.
Avenida Pierre Simon De Laplace, 600
Campinas,  BR 13069320
Applicant Contact Guilherme Esteves Pontes
Correspondent
GM Dos Reis Industria e Comercio Ltda.
Avenida Pierre Simon De Laplace, 600
Campinas,  BR 13069320
Correspondent Contact Guilherme Esteves Pontes
Regulation Number878.5000
Classification Product Code
GAT  
Date Received12/08/2025
Decision Date 08/22/2026
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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