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 IDK150698
510k NumberK150698
Device Name:Gemini Sterilization Wrap
ClassificationWrap, Sterilization
Applicant MEDLINE INDUSTRIES, INC. 1 MEDLINE PLACE Mundelein,  IL  60060
ContactJennifer Mason
CorrespondentJennifer Mason
MEDLINE INDUSTRIES, INC. 1 MEDLINE PLACE Mundelein,  IL  60060
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-18
Decision Date2015-11-20
Summary:summary

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