DURA BLUE 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 Dura Blue Sterilization Wrap.

Pre-market Notification Details

Device IDK112211
510k NumberK112211
Device Name:DURA BLUE STERILIZATION WRAP
ClassificationWrap, Sterilization
Applicant CARDINAL HEALTH 200, LLC 1430 WAUKEGAAN ROAD Waukegan,  IL  60085
ContactLavenia Ford
CorrespondentNed Devine
UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook,  IL  60062
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2011-08-02
Decision Date2011-10-20
Summary:summary

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