VenaOne

Sleeve, Limb, Compressible

Vena Group, LLC

The following data is part of a premarket notification filed by Vena Group, Llc with the FDA for Venaone.

Pre-market Notification Details

Device IDK200285
510k NumberK200285
Device Name:VenaOne
ClassificationSleeve, Limb, Compressible
Applicant Vena Group, LLC 10 Westelm Gardens San Antonio,  TX  78230
ContactKasey Vukson
CorrespondentBill Quanqin Dai
JKH USA, LLC 14271 Jeffrey Rd. #246 Irvine,  CA  92620
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-05
Decision Date2020-07-02

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