MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD

Mask, Surgical

MEDLINE INDUSTRIES, INC.

The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Prohibit Series Surgical Mask With Fluid Shield.

Pre-market Notification Details

Device IDK991559
510k NumberK991559
Device Name:MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD
ClassificationMask, Surgical
Applicant MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
ContactLara N Simmons
CorrespondentLara N Simmons
MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-05-04
Decision Date1999-08-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
40080196754404 K991559 000
30080196752953 K991559 000

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