Medline Quick-Clear Wand

Tubes, Gastrointestinal (and Accessories)

Medline Industries, Inc.

The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Quick-clear Wand.

Pre-market Notification Details

Device IDK183577
510k NumberK183577
Device Name:Medline Quick-Clear Wand
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
ContactDinah Rincones
CorrespondentDinah Rincones
Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-21
Decision Date2019-05-04

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