SterilContainer S2 System

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Aesculap, Inc.

The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Sterilcontainer S2 System.

Pre-market Notification Details

Device IDK193582
510k NumberK193582
Device Name:SterilContainer S2 System
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant Aesculap, Inc. 3773 Corporate Parkway Center Valley,  PA  18034
ContactSierra Mertz
CorrespondentSierra Mertz
Aesculap, Inc. 3773 Corporate Parkway Center Valley,  PA  18034
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
510k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-23
Decision Date2020-03-17

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