STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE

Drape, Surgical

MEDLINE INDUSTRIES, INC.

The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Sterile And Non-sterile O.r. Towels, Sterile And Non-sterile X-ray Detectable O.r. Towels, Single Use.

Pre-market Notification Details

Device IDK962205
510k NumberK962205
Device Name:STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE
ClassificationDrape, Surgical
Applicant MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060 -4486
ContactLara N Simmons
CorrespondentLara N Simmons
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 Received1996-06-07
Decision Date1996-11-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00653160373868 K962205 000

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