K-number	K210745
Device name	Heel Incision Safety Lancet
Applicant	SteriLance Medical (Suzhou), Inc.
Product code	FMK
Device class	Class II
Decision date	Aug 26, 2021
Decision	Substantially Equivalent
Regulation	878.4850

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Source

View the full FDA submission: accessdata.fda.gov

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Heel Incision Safety Lancet

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