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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K200053
Device Name DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)
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 Number876.1500
Classification Product Code
GCJ  
Date Received01/10/2020
Decision Date 04/21/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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