Heel Incision Safety Lancet

Lancet, Blood

SteriLance Medical (Suzhou) Inc.

The following data is part of a premarket notification filed by Sterilance Medical (suzhou) Inc. with the FDA for Heel Incision Safety Lancet.

Pre-market Notification Details

Device IDK210745
510k NumberK210745
Device Name:Heel Incision Safety Lancet
ClassificationLancet, Blood
Applicant SteriLance Medical (Suzhou) Inc. No.168 PuTuoShan Road, New District Suzhou,  CN 215153
ContactYuan Jie
CorrespondentJoyce Yang
Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen,  CN 518100
Product CodeFMK  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-12
Decision Date2021-08-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06945630109843 K210745 000
36945630113605 K210745 000
36945630113612 K210745 000
36945630113629 K210745 000
36945630114992 K210745 000
36945630115005 K210745 000
36945630115012 K210745 000
06945630125522 K210745 000
36945630121808 K210745 000
36945630121815 K210745 000
06945630121821 K210745 000
36945630124106 K210745 000
06945630109829 K210745 000
06945630109836 K210745 000
36945630113599 K210745 000

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