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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 K212407
Device Name Gastric Lightguide (GLG)
Applicant
Naser Dib Gabinet Lekarksi Nasmed
Ul Jana Nowaka Jezioranskiego 7/184
Warszawa,  PL 03-984
Applicant Contact Naser Dib
Correspondent
Aztech Regulatory & Quality, LLC
543 Long Hill Ave.
Shelton,  CT  06484
Correspondent Contact Joseph Azary
Regulation Number876.5980
Classification Product Code
KNT  
Date Received08/03/2021
Decision Date 07/26/2022
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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