K-number	K925875
Device name	HORIZONTAL NEEDLE GUIDE ATTACHMENT
Applicant	Bip USA, Inc.
Product code	GDF
Device class	Class I
Decision date	Apr 6, 1993
Decision	Substantially Equivalent
Regulation	878.4800

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Source

View the full FDA submission: accessdata.fda.gov

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HORIZONTAL NEEDLE GUIDE ATTACHMENT

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