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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name endoscopic access overtube, gastroenterology-urology
510(k) Number K191415
Device Name Pathfinder Endoscope Overtube
Neptune Medical, Inc.
1828 El Camino Real, Suite 508
Burlingame,  CA  94010
Applicant Contact Alex Tilson
AlvaMed, Inc.
935 Great Plain Avenue, #166
Needham,  MA  02492
Correspondent Contact Ian Broome
Regulation Number876.1500
Classification Product Code
Date Received05/28/2019
Decision Date 08/30/2019
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