Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)

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

Tianjin Huahong Technology Co., Ltd.

The following data is part of a premarket notification filed by Tianjin Huahong Technology Co., Ltd. with the FDA for Safety Lancet (xiii, Xvii, Xxi, Xxii, Xxiii, Xxiv, Xxv, Xxvi).

Pre-market Notification Details

Device IDK220370
510k NumberK220370
Device Name:Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)
ClassificationSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Applicant Tianjin Huahong Technology Co., Ltd. A01, Plant B, No. 278, Hangkong Road, Tianjin Pilot Free Trade Zone(Air Port Industrial Park) Tianjin,  CN 300308
ContactYuan Ying
CorrespondentStuart Situ
Landlink Healthcare Technology (Shanghai) Co., Ltd Room 1308, Baohua International Plaza,West Guangzhong Road 555, Jingan District Shanghai,  CN 200072
Product CodeFMK  
CFR Regulation Number878.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-09
Decision Date2022-05-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
80816042013535 K220370 000
80816042013542 K220370 000

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