Gemini Titan 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 Titan Sterilization Wrap.

Pre-market Notification Details

Device IDK192641
510k NumberK192641
Device Name:Gemini Titan Sterilization Wrap
ClassificationWrap, Sterilization
Applicant Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
ContactJennifer Mason
CorrespondentJennifer Mason
Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
510k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-24
Decision Date2020-01-24

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