K-number	K880288
Device name	TRU-TRAC TORQUE GUIDEWIRE
Applicant	N-S Medical Products
Product code	DQX
Device class	Class II
Decision date	Sep 12, 1988
Decision	Substantially Equivalent
Regulation	870.1330

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View the full FDA submission: accessdata.fda.gov

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TRU-TRAC TORQUE GUIDEWIRE

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