K-number	K230671
Device name	Pitch PaSoft Tissue Reinforcement Device
Applicant	Xiros, Ltd.
Product code	FTL
Device class	Class II
Decision date	May 31, 2023
Decision	Substantially Equivalent
Regulation	878.3300

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Source

View the full FDA submission: accessdata.fda.gov

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Pitch PaSoft Tissue Reinforcement Device

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