K-number	K031493
Device name	GROWTH GUIDANCE PLATE
Applicant	University of Utah/School of Medicine
Product code	HRS
Device class	Class II
Decision date	Nov 20, 2003
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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GROWTH GUIDANCE PLATE

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