Sweden & Martina Surgical Tray (Model ZSHORTY-INT)

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sweden & Martina S.p.A.

The following data is part of a premarket notification filed by Sweden & Martina S.p.a. with the FDA for Sweden & Martina Surgical Tray (model Zshorty-int).

Pre-market Notification Details

Device IDK182084
510k NumberK182084
Device Name:Sweden & Martina Surgical Tray (Model ZSHORTY-INT)
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant Sweden & Martina S.p.A. via Veneto 10 Due Carrare,  IT 35020
ContactAlessia Pezzato
CorrespondentAlessia Pezzato
Sweden & Martina S.p.A. via Veneto 10 Due Carrare,  IT 35020
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-02
Decision Date2020-11-04

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