K-number	K000737
Device name	COAXIAL DILATOR SET
Applicant	Xentek Medical, Inc.
Product code	DRE
Device class	Class II
Decision date	Aug 1, 2000
Decision	Substantially Equivalent
Regulation	870.1310

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Source

View the full FDA submission: accessdata.fda.gov

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COAXIAL DILATOR SET

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