K-number	K210569
Device name	Disposable Monopolar Laparoscopic Shafts and Reusable Handles
Applicant	Dannik, LLC
Product code	GEI
Device class	Class II
Decision date	Aug 16, 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 Shafts and Reusable Handles

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