K-number	K241858
Device name	BARS Set (100.60)
Applicant	Ovesco Endoscopy AG
Product code	PKL
Device class	Class II
Decision date	Aug 26, 2024
Decision	Substantially Equivalent
Regulation	876.4400

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Source

View the full FDA submission: accessdata.fda.gov

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BARS Set (100.60)

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