Name: Predicase
Price: 199 USD

K-number	K080220
Device name	PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE
Applicant	Italia Medica S.R.L.
Product code	DZI
Device class	Class II
Decision date	Jul 28, 2008
Decision	Substantially Equivalent
Regulation	872.4120

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Source

View the full FDA submission: accessdata.fda.gov

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PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE

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