K-number	K950267
Device name	URETHRAL SUTURE GUIDE
Applicant	Applied Medical Resources
Product code	KOA
Device class	Class I
Decision date	Jan 31, 1995
Decision	Substantially Equivalent
Regulation	876.4730

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View the full FDA submission: accessdata.fda.gov

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URETHRAL SUTURE GUIDE

Everything you need for a 510(k) submission. Nothing you don't.