Genesis Reusable Rigid Container System

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

CareFusion 2200 Inc

The following data is part of a premarket notification filed by Carefusion 2200 Inc with the FDA for Genesis Reusable Rigid Container System.

Pre-market Notification Details

Device IDK142529
510k NumberK142529
Device Name:Genesis Reusable Rigid Container System
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant CareFusion 2200 Inc 75 N Fairway Drive Vernon Hills,  IL  60061
ContactJane Weber
CorrespondentJane Weber
CareFusion 2200 Inc 75 N Fairway Drive Vernon Hills,  IL  60061
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-09
Decision Date2015-01-08
Summary:summary

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