K-number	K864219
Device name	TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE
Applicant	Amedic USA
Product code	HGL
Device class	Class II
Decision date	Mar 27, 1987
Decision	Substantially Equivalent
Regulation	884.2960

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View the full FDA submission: accessdata.fda.gov

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TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE

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