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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 K240069
Device Name Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)
Applicant
Endolumik
364 Patteson Dr. #293
Morgantown,  WV  26505
Applicant Contact Mara McFadden
Correspondent
Nilo Medical Consulting Group
3706 Butler Street, #313
Pittsburgh,  PA  15201
Correspondent Contact Michael Nilo
Regulation Number876.5980
Classification Product Code
KNT  
Subsequent Product Code
FAT  
Date Received01/09/2024
Decision Date 02/08/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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