K-number	K970416
Device name	ACUFEX DOUBLE ARMED SUTURE NEEDLE
Applicant	Smith & Nephew Endoscopy, Inc.
Product code	GAT
Device class	Class II
Decision date	Apr 21, 1997
Decision	Substantially Equivalent
Regulation	878.5000

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View the full FDA submission: accessdata.fda.gov

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ACUFEX DOUBLE ARMED SUTURE NEEDLE

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