VariLymph 12 Pro

Sleeve, Limb, Compressible

SLK Medical GmbH

The following data is part of a premarket notification filed by Slk Medical Gmbh with the FDA for Varilymph 12 Pro.

Pre-market Notification Details

Device IDK193476
510k NumberK193476
Device Name:VariLymph 12 Pro
ClassificationSleeve, Limb, Compressible
Applicant SLK Medical GmbH Oberste-Wilms-Str. 15a Dortmund,  DE 44309
ContactMatthew Reid
CorrespondentMatthew Reid
SLK Medical GmbH Oberste-Wilms-Str. 15a Dortmund,  DE 44309
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-16
Decision Date2020-08-19

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