Medline Anti-Fog Solution

Anti Fog Solution And Accessories, Endoscopy

Medline Industries, Inc.

The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Anti-fog Solution.

Pre-market Notification Details

Device IDK152948
510k NumberK152948
Device Name:Medline Anti-Fog Solution
ClassificationAnti Fog Solution And Accessories, Endoscopy
Applicant Medline Industries, Inc. One Medline Place Mundelein,  IL  60060
ContactMatt Clausen
CorrespondentMatt Clausen
Medline Industries, Inc. One Medline Place Mundelein,  IL  60060
Product CodeOCT  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-10-06
Decision Date2016-02-04

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