OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance And Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Asahi Polyslider Co., Ltd.

The following data is part of a premarket notification filed by Asahi Polyslider Co., Ltd. with the FDA for Onetouch Delica Safety, Hemocue Safety Lancet, Assure Lance And Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie.

Pre-market Notification Details

Device IDK222084
510k NumberK222084
Device Name:OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance And Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie
ClassificationSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Applicant Asahi Polyslider Co., Ltd. 860-2 Misaki Maniwa,  JP 719-3226
ContactYoshitaka Akagi
CorrespondentStuart R Goldman
Emergo By UL 2500 Bee Cave Road Bldg. 1, Suite 300 Austin,  TX  78746
Product CodeFMK  
CFR Regulation Number878.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-15
Decision Date2022-11-02

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