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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 K211301
Device Name Pathfinder Endoscope Overtube
Applicant
Neptune Medical, Inc.
1828 El Camino Real
Burlingame,  CA  94010
Applicant Contact Alex Tilson
Correspondent
AlvaMed, Inc.
935 Great Plain Ave.
Suite 166
Needham,  MA  02492
Correspondent Contact Ian Broome
Regulation Number876.1500
Classification Product Code
FED  
Date Received04/29/2021
Decision Date 05/28/2021
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
Predetermined Change
Control Plan Authorized		 No
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