Cardinal Health Sterilization Wrap

Wrap, Sterilization

Cardinal Health 200 LLC

The following data is part of a premarket notification filed by Cardinal Health 200 Llc with the FDA for Cardinal Health Sterilization Wrap.

Pre-market Notification Details

Device IDK181174
510k NumberK181174
Device Name:Cardinal Health Sterilization Wrap
ClassificationWrap, Sterilization
Applicant Cardinal Health 200 LLC 3651 Birchwood Drive Waukegan,  IL  60085
ContactJillian Connery
CorrespondentJillian Connery
Cardinal Health 200 LLC 3651 Birchwood Drive Waukegan,  IL  60085
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-02
Decision Date2018-12-11
Summary:summary

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