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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 K212404
Device Name S.I.N. Instrument Kits
S.I.N. - Sistema de Implante Nacional S.A.
Avenida Vereador Abel Ferreira, 1100
São Paulo,  BR 03340-000
Applicant Contact Denise Domiciano
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego,  CA  92130
Correspondent Contact Kevin A. Thomas
Regulation Number880.6850
Classification Product Code
Date Received08/02/2021
Decision Date 11/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No