Medline Hemo-Force DVT Compression Sleeve

Sleeve, Limb, Compressible

Medline Industries, Inc.

The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Hemo-force Dvt Compression Sleeve.

Pre-market Notification Details

Device IDK170415
510k NumberK170415
Device Name:Medline Hemo-Force DVT Compression Sleeve
ClassificationSleeve, Limb, Compressible
Applicant Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
ContactMatt Clausen
CorrespondentMatt Clausen
Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-10
Decision Date2017-09-08

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