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

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