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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonic Irrigation System
510(k) Number K201861
Device Name Bio Fluff System
Applicant
Gnali Bocia S.R.L.
Via Brescia, 41/M-N
Lumezzane,  IT 25065
Applicant Contact Katy Gnali
Correspondent
Gnali Bocia S.R.L.
Via Brescia, 41/M-N
Lumezzane,  IT 25065
Correspondent Contact Katy Gnali
Regulation Number876.5220
Classification Product Code
KPL  
Date Received07/06/2020
Decision Date 03/02/2022
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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