Name: Predicase
Price: 199 USD

K-number	K220917
Device name	gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler
Applicant	Gri-Alleset, Inc.
Product code	FMK
Device class	Class II
Decision date	May 18, 2022
Decision	Substantially Equivalent
Regulation	878.4850

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Source

View the full FDA submission: accessdata.fda.gov

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gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler

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