Name: Predicase
Price: 199 USD

K-number	K992994
Device name	TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS;
Applicant	Gyrus Ent LLC
Product code	ERL
Device class	Class II
Decision date	Nov 23, 1999
Decision	Substantially Equivalent
Regulation	874.4250

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Source

View the full FDA submission: accessdata.fda.gov

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TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS;

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