MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS

Drape, Surgical

MEDLINE INDUSTRIES, INC.

The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Disposable Surgical Drapes And Gowns.

Pre-market Notification Details

Device IDK964142
510k NumberK964142
Device Name:MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS
ClassificationDrape, Surgical
Applicant MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060 -4486
ContactChristine Galea
CorrespondentChristine Galea
MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060 -4486
Product CodeKKX  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-10-16
Decision Date1997-02-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30801902048524 K964142 000
30801902055102 K964142 000
20801902198864 K964142 000
30801902099380 K964142 000

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