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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, upper urinary tract
510(k) Number K200757
Device Name Foley Catheter with Temperature Sensor
Applicant
DeRoyal Industries, Inc.
200 DeBusk Lane
Powell,  TN  37849
Applicant Contact Sarah Bennett
Correspondent
DeRoyal Industries, Inc.
200 DeBusk Lane
Powell,  TN  37849
Correspondent Contact Sarah Bennett
Regulation Number876.5130
Classification Product Code
EYC  
Date Received03/24/2020
Decision Date 10/15/2020
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
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