K-number	K242664
Device name	gentleheel® Adult Incision Device
Applicant	Gri-Alleset, Inc.
Product code	FMK
Device class	Class II
Decision date	Nov 5, 2024
Decision	Substantially Equivalent
Regulation	878.4850

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Source

View the full FDA submission: accessdata.fda.gov

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gentleheel® Adult Incision Device

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