Name: Predicase
Price: 199 USD

K-number	K220179
Device name	High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors
Applicant	Foshan Coxo Medical Instrument Co., Ltd.
Product code	EFB
Device class	Class I
Decision date	Sep 22, 2023
Decision	Substantially Equivalent
Regulation	872.4200

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Source

View the full FDA submission: accessdata.fda.gov

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High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors

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