K-number	K181094
Device name	Polydioxanone Surgical Scaffold
Applicant	Lntegra Lifesciences
Product code	FTL
Device class	Class II
Decision date	Aug 2, 2018
Decision	Substantially Equivalent
Regulation	878.3300

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Source

View the full FDA submission: accessdata.fda.gov

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Polydioxanone Surgical Scaffold

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