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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 K192499
Device Name Cyber Blade
Applicant
Sidam Srl
Via Statale Sud, 169
Mirandola (Mo),  IT 41037
Applicant Contact Andrea Tromba
Correspondent
Sidam Srl
Via Statale Sud, 169
Mirandola (Mo),  IT 41037
Correspondent Contact Andrea Tromba
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/11/2019
Decision Date 07/31/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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