SterilContainer S 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 S System.

Pre-market Notification Details

Device IDK142970
510k NumberK142970
Device Name:SterilContainer S System
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant AESCULAP, INC. 3773 Corporate Parkway Center Valley,  PA  18034
ContactDenise R Adams
CorrespondentDenise R Adams
AESCULAP, INC. 3773 Corporate Parkway Center Valley,  PA  18034
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-14
Decision Date2015-07-08
Summary:summary

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