K-number	K931403
Device name	SITERITE NEEDLE GUIDE (MODIFIED)
Applicant	Dymax Corp
Product code	DQY
Device class	Class II
Decision date	Jul 27, 1993
Decision	Substantially Equivalent
Regulation	870.1250

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View the full FDA submission: accessdata.fda.gov

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SITERITE NEEDLE GUIDE (MODIFIED)

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