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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
510(k) Number K193169
Device Name Nelson Sentinel Series Basic Chlorine Sentinel
Applicant
Nelson Environmental Technologies, Inc.
813 E Fir Ave.
Mcallen,  TX  78501
Applicant Contact QuocHuy (Huy) Nquyen
Correspondent
Nelson Environmental Technologies, Inc.
813 E Fir Ave.
Mcallen,  TX  78501
Correspondent Contact QuocHuy (Huy) Nquyen
Regulation Number876.5665
Classification Product Code
MSY  
Date Received11/15/2019
Decision Date 10/29/2020
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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