K-number	K903158
Device name	SITERITE NEEDLE GUIDE
Applicant	Dymax Corp
Product code	DQY
Device class	Class II
Decision date	Sep 27, 1990
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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SITERITE NEEDLE GUIDE

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