Gemini Bonded Sterilization Wrap

Wrap, Sterilization

MEDLINE INDUSTRIES, INC.

The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Gemini Bonded Sterilization Wrap.

Pre-market Notification Details

Device IDK152458
510k NumberK152458
Device Name:Gemini Bonded Sterilization Wrap
ClassificationWrap, Sterilization
Applicant MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
ContactJennifier Mason
CorrespondentJennifier Mason
MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-28
Decision Date2016-06-01
Summary:summary

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