LIFEGUARD SAFETY INFUSION SET

Set, Administration, Intravascular

HORIZON MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Horizon Medical Products, Inc. with the FDA for Lifeguard Safety Infusion Set.

Pre-market Notification Details

Device IDK013871
510k NumberK013871
Device Name:LIFEGUARD SAFETY INFUSION SET
ClassificationSet, Administration, Intravascular
Applicant HORIZON MEDICAL PRODUCTS, INC. 1 HORIZON WAY Manchester,  GA  31816
ContactPatricia D Jones
CorrespondentPatricia D Jones
HORIZON MEDICAL PRODUCTS, INC. 1 HORIZON WAY Manchester,  GA  31816
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-11-21
Decision Date2002-03-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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H787LG19100NY5 K013871 000
H787LG19755 K013871 000
H787LG1975NY5 K013871 000
H787LGV22755 K013871 000

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