K-number	K001440
Device name	NEXTSTITCH CARDIOVASCULAR VALVE SUTURE
Applicant	Genzyme Surgical Product (Genzyme Biosurgery)
Product code	GAT
Device class	Class II
Decision date	Nov 13, 2000
Decision	Substantially Equivalent
Regulation	878.5000

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Source

View the full FDA submission: accessdata.fda.gov

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NEXTSTITCH CARDIOVASCULAR VALVE SUTURE

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