HLIC NEEDLE-LESS VALVE

Set, Administration, Intravascular

HEALTH LINE INTERNATIONAL CORPORATION

The following data is part of a premarket notification filed by Health Line International Corporation with the FDA for Hlic Needle-less Valve.

Pre-market Notification Details

Device IDK120548
510k NumberK120548
Device Name:HLIC NEEDLE-LESS VALVE
ClassificationSet, Administration, Intravascular
Applicant HEALTH LINE INTERNATIONAL CORPORATION 803 N. 1250 W. SUITE 1 Centerville,  UT  84014
ContactNola Benstog
CorrespondentNola Benstog
HEALTH LINE INTERNATIONAL CORPORATION 803 N. 1250 W. SUITE 1 Centerville,  UT  84014
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-02-23
Decision Date2012-05-04
Summary:summary

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