Name: Predicase
Price: 199 USD

K-number	K222168
Device name	Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler
Applicant	Owen Mumford, Ltd.
Product code	FMK
Device class	Class II
Decision date	Nov 3, 2022
Decision	Substantially Equivalent
Regulation	878.4850

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Source

View the full FDA submission: accessdata.fda.gov

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Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler

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