Facet 28G Universal Lancet

Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Facet Technologies LLC

The following data is part of a premarket notification filed by Facet Technologies Llc with the FDA for Facet 28g Universal Lancet.

Pre-market Notification Details

Device IDK221433
510k NumberK221433
Device Name:Facet 28G Universal Lancet
ClassificationSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Applicant Facet Technologies LLC 3900 N. Commerce Dr. Atlanta,  GA  30344
ContactJames Bonds
CorrespondentJames Bonds
Facet Technologies LLC 3900 N. Commerce Dr. Atlanta,  GA  30344
Product CodeQRK  
CFR Regulation Number878.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-17
Decision Date2022-07-15

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