Gemini 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 Sterilization Wrap.

Pre-market Notification Details

Device IDK162993
510k NumberK162993
Device Name:Gemini Sterilization Wrap
ClassificationWrap, Sterilization
Applicant Medline Industries, Inc. One Medline Place Mundelein,  IL  60060
ContactJennifer Mason
CorrespondentJennifer 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 Received2016-10-27
Decision Date2017-06-23
Summary:summary

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