Disposable Monopolar Laparoscopic Tips And Reusable Handles

Electrosurgical, Cutting & Coagulation & Accessories

Dannik LLC

The following data is part of a premarket notification filed by Dannik Llc with the FDA for Disposable Monopolar Laparoscopic Tips And Reusable Handles.

Pre-market Notification Details

Device IDK211019
510k NumberK211019
Device Name:Disposable Monopolar Laparoscopic Tips And Reusable Handles
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Dannik LLC 941 W. Morse Blvd Suite 100 Winter Park,  FL  32789
ContactOlga Haberland
CorrespondentOlga Haberland
Dannik LLC 941 W. Morse Blvd Suite 100 Winter Park,  FL  32789
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-05
Decision Date2021-10-28

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