Name: Predicase
Price: 199 USD

K-number	K100389
Device name	HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT
Applicant	Handpiece Headquarters
Product code	EFB
Device class	Class I
Decision date	Aug 12, 2010
Decision	Substantially Equivalent
Regulation	872.4200

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Source

View the full FDA submission: accessdata.fda.gov

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HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT

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