K-number	K212810
Device name	MONOFIX PGCL, knotless wound closure device
Applicant	Samyang Holdings Corp., Ltd.
Product code	GAM
Device class	Class II
Decision date	Aug 5, 2022
Decision	Substantially Equivalent
Regulation	878.4493

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Source

View the full FDA submission: accessdata.fda.gov

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MONOFIX PGCL, knotless wound closure device

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