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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K262084
Device Name S.I.N. Instruments Kits
Applicant
S.I.N. Implant System Ltda
Rua Soldado Ocimar Gumarães Da Silva, 421
São Paulo,  BR 03348-060
Applicant Contact Denise Domiciano
Correspondent
S.I.N. Implant System Ltda
Rua Soldado Ocimar Gumarães Da Silva, 421
São Paulo,  BR 03348-060
Correspondent Contact Denise Domiciano
Regulation Number880.6850
Classification Product Code
KCT  
Date Received06/22/2026
Decision Date 10/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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