K-number	K211019
Device name	Disposable Monopolar Laparoscopic Tips and Reusable Handles
Applicant	Dannik, LLC
Product code	GEI
Device class	Class II
Decision date	Oct 28, 2021
Decision	Substantially Equivalent
Regulation	878.4400

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Source

View the full FDA submission: accessdata.fda.gov

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Disposable Monopolar Laparoscopic Tips and Reusable Handles

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