K-number	K032015
Device name	EMBRYON ULTRASOUND NEEDLE GUIDE
Applicant	Rocket Medical Plc
Product code	MQE
Device class	Class II
Decision date	Aug 8, 2003
Decision	Substantially Equivalent
Regulation	884.6100

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View the full FDA submission: accessdata.fda.gov

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EMBRYON ULTRASOUND NEEDLE GUIDE

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