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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 K210569
Device Name Disposable Monopolar Laparoscopic Shafts and Reusable Handles
Applicant
Dannik, LLC
941 W. Morse Blvd. Suite 100
Winter Park,  FL  32789
Applicant Contact Olga Haberland
Correspondent
Dannik, LLC
941 W. Morse Blvd. Suite 100
Winter Park,  FL  32789
Correspondent Contact Olga Haberland
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/26/2021
Decision Date 08/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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