K-number	K963320
Device name	TFX MEDICAL GUIDEWIRE
Applicant	Tfx Medical Group
Product code	DQX
Device class	Class II
Decision date	Dec 3, 1996
Decision	Substantially Equivalent
Regulation	870.1330

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View the full FDA submission: accessdata.fda.gov

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TFX MEDICAL GUIDEWIRE

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