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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Irrigation/Suction System
510(k) Number K222173
Device Name Saneso Lens Wash Bottle Assembly (SAN-LWB-A)
Applicant
Saneso, Inc.
One Oxford Center, 301 Grant St.
Suite 4300
Pittsburgh,  PA  15219
Applicant Contact Nitesh Ratnakar
Correspondent
Elexes Medical Consulting, LLC
30 N Gould St., Suite R
Sheridan,  WY  82801
Correspondent Contact Parul Chansoria
Regulation Number876.1500
Classification Product Code
OCX  
Date Received07/21/2022
Decision Date 02/27/2023
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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