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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
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