S.I.N. Instrument Kits

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

S.I.N. - Sistema De Implante Nacional S.A.

The following data is part of a premarket notification filed by S.i.n. - Sistema De Implante Nacional S.a. with the FDA for S.i.n. Instrument Kits.

Pre-market Notification Details

Device IDK212404
510k NumberK212404
Device Name:S.I.N. Instrument Kits
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant S.I.N. - Sistema De Implante Nacional S.A. Avenida Vereador Abel Ferreira, 1100 São Paulo,  BR 03340-000
ContactDenise Domiciano
CorrespondentKevin A. Thomas
PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego,  CA  92130
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-02
Decision Date2021-11-03

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