Name: Predicase
Price: 199 USD

K-number	K051947
Device name	RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE
Applicant	Radionics, A Division of Tyco Healthcare Group LP
Product code	LFL
Device class	Class U
Decision date	Aug 22, 2005
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE

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