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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K201063
Device Name DANNIK Disposable Monopolar Laparoscopic Instrument
Applicant
Dannik
941 W. Morse Blvd. Suite 100
Winter Park,  FL  32789
Applicant Contact Olga Haberlad
Correspondent
Dannik
941 W. Morse Blvd. Suite 100
Winter Park,  FL  32789
Correspondent Contact Olga Haberland
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/21/2020
Decision Date 06/09/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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