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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 K222880
Device Name Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)
Applicant
Endolumik, Inc.
364 Patteson Dr. #293
Morgantown,  WV  26505
Applicant Contact Mara McFadden
Correspondent
Nilo Medical Consulting Group
3491 Denny St.
Pittsburg,  PA  15201
Correspondent Contact Michael Nilo
Regulation Number876.5980
Classification Product Code
KNT  
Date Received09/22/2022
Decision Date 03/03/2023
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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