Name: Predicase
Price: 199 USD

K-number	K083802
Device name	SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025
Applicant	Medi-Globe Corporation
Product code	FCG
Device class	Class II
Decision date	Mar 20, 2009
Decision	Substantially Equivalent
Regulation	876.1075

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Source

View the full FDA submission: accessdata.fda.gov

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SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025

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