Insta-Gard Surgical And Procedure Face Mask

Mask, Surgical

Cardinal Health 200, LLC

The following data is part of a premarket notification filed by Cardinal Health 200, Llc with the FDA for Insta-gard Surgical And Procedure Face Mask.

Pre-market Notification Details

Device IDK142990
510k NumberK142990
Device Name:Insta-Gard Surgical And Procedure Face Mask
ClassificationMask, Surgical
Applicant Cardinal Health 200, LLC 1500 Waukegan Road Waukegan,  IL  60085
ContactLavenia Ford
CorrespondentLavenia Ford
Cardinal Health 200, LLC 1500 Waukegan Road Waukegan,  IL  60085
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-16
Decision Date2015-03-04
Summary:summary

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