ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM

Apparatus, Suction, Ward Use, Portable, Ac-powered

Cardinal Health

The following data is part of a premarket notification filed by Cardinal Health with the FDA for Orwell Fluid Collection And Disposal System.

Pre-market Notification Details

Device IDK080845
510k NumberK080845
Device Name:ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM
ClassificationApparatus, Suction, Ward Use, Portable, Ac-powered
Applicant Cardinal Health 1500 WAUKEGAN RD. BLDG. WM Mcgaw Park,  IL  60085
ContactLavenia Ford
CorrespondentNed Devine
UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook,  IL  60062
Product CodeJCX  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2008-03-26
Decision Date2008-04-30
Summary:summary

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