Avinent Surgical Tray

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

AVINENT Implant System, S.L.U.

The following data is part of a premarket notification filed by Avinent Implant System, S.l.u. with the FDA for Avinent Surgical Tray.

Pre-market Notification Details

Device IDK191566
510k NumberK191566
Device Name:Avinent Surgical Tray
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant AVINENT Implant System, S.L.U. Pol. Ind. Santa Anna Santpedor,  ES 08251
ContactAnna Cortina
CorrespondentAngela Blackwell
Blackwell Device Consulting P.O. Box 718 Gresham,  OR  97030 -0172
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
510k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-13
Decision Date2020-03-06

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