Name: Predicase
Price: 199 USD

K-number	K080089
Device name	SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS
Applicant	Sybron Dental Specialties, Inc.
Product code	ELC
Device class	Class II
Decision date	Sep 4, 2008
Decision	Substantially Equivalent
Regulation	872.4850

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Source

View the full FDA submission: accessdata.fda.gov

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SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS

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