VIALOK NON-VENTED

Set, I.v. Fluid Transfer

YUKON MEDICAL, LLC

The following data is part of a premarket notification filed by Yukon Medical, Llc with the FDA for Vialok Non-vented.

Pre-market Notification Details

Device IDK121182
510k NumberK121182
Device Name:VIALOK NON-VENTED
ClassificationSet, I.v. Fluid Transfer
Applicant YUKON MEDICAL, LLC 4819-400 EMPEROR BLVD Durham,  NC  27703
ContactCarl Dupper
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeLHI  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2012-04-18
Decision Date2012-05-03
Summary:summary

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