Name: Predicase
Price: 199 USD

K-number	K010497
Device name	SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300
Applicant	Micro Therapeutics, Inc.
Product code	DQX
Device class	Class II
Decision date	Mar 22, 2001
Decision	Substantially Equivalent
Regulation	870.1330

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Source

View the full FDA submission: accessdata.fda.gov

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SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300

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