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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Implantable
510(k) Number K192711
Device Name Dannik Titanium Ligation Clip
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 Haberlad
Regulation Number878.4300
Classification Product Code
FZP  
Date Received09/27/2019
Decision Date 12/20/2019
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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