K-number	K022655
Device name	TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH
Applicant	Trimedyne, Inc.
Product code	GEX
Device class	Class II
Decision date	Nov 7, 2002
Decision	Substantially Equivalent
Regulation	878.4810

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View the full FDA submission: accessdata.fda.gov

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TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH

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