K-number	K013990
Device name	LIFESTITCH SUTURING DEVICE
Applicant	Edwards Lifesciences, LLC
Product code	GAT
Device class	Class II
Decision date	Feb 27, 2002
Decision	Substantially Equivalent
Regulation	878.5000

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Source

View the full FDA submission: accessdata.fda.gov

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LIFESTITCH SUTURING DEVICE

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