Name: Predicase
Price: 199 USD

K-number	K201884
Device name	ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm
Applicant	Microline Surgical, Inc.
Product code	GEI
Device class	Class II
Decision date	Oct 21, 2020
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm

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