Name: Predicase
Price: 199 USD

K-number	K190827
Device name	Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid
Applicant	Uvision360, Inc.
Product code	HIH
Device class	Class II
Decision date	Jun 6, 2019
Decision	Substantially Equivalent
Regulation	884.1690

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Source

View the full FDA submission: accessdata.fda.gov

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Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid

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