Medline Burn And Wound Dressing (OTC)

Dressing, Wound, Drug

Medline Industries, Inc.

The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Burn And Wound Dressing (otc).

Pre-market Notification Details

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Device IDK190224
510k NumberK190224
Device Name:Medline Burn And Wound Dressing (OTC)
ClassificationDressing, Wound, Drug
Applicant Medline Industries, Inc. Three Lake Drive Northfield,  IL  60093
ContactClaire Pigman
CorrespondentClaire Pigman
Medline Industries, Inc. Three Lake Drive Northfield,  IL  60093
Product CodeFRO  
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2019-02-05
Decision Date2019-03-08
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