DANNIK Disposable Monopolar Laparoscopic Instrument

Electrosurgical, Cutting & Coagulation & Accessories

Dannik

The following data is part of a premarket notification filed by Dannik with the FDA for Dannik Disposable Monopolar Laparoscopic Instrument.

Pre-market Notification Details

Device IDK193019
510k NumberK193019
Device Name:DANNIK Disposable Monopolar Laparoscopic Instrument
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Dannik 941 W Morse Blvd. Suite 100 Winter Park,  FL  32789
ContactOlga Haberlad
CorrespondentOlga Haberland
Dannik 941 W Morse Blvd. Suite 100 Winter Park,  FL  32789
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-29
Decision Date2020-03-04

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