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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 K201688
Device Name S.I.N. Instrument Kits
Applicant
S.I.N. - Sistema de Implante Nacional S.A.
Avenida Vereador Abel Ferreira, 1100
São Paulo,  BR 03340-000
Applicant Contact Denise Domiciano
Correspondent
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego,  CA  92130
Correspondent Contact Kevin A. Thomas
Regulation Number880.6850
Classification Product Code
KCT  
Date Received06/22/2020
Decision Date 10/21/2020
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
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