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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K221400
Device Name hygh-tec drainage
Applicant
Creative Balloons GmbH
Bruchsaler Straße 22
Waghäusel,  DE 68753
Applicant Contact Claudia Falk
Correspondent
Nilo Medical Consulting Group
3491 Denny St.
Pittsburg,  PA  15201
Correspondent Contact Michael Nilo
Regulation Number876.5980
Classification Product Code
KNT  
Date Received05/16/2022
Decision Date 02/09/2023
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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