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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 K222005
Device Name S.I.N. Instrument Kits
Applicant
S.I.N. - Sistema De Implante Nacional S.A.
Avenida Vereador Abel Ferreira, 1100
Sao 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 Received07/07/2022
Decision Date 09/29/2022
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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