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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mobile / tablet software application to control settings of surgical and endoscopic camera
510(k) Number K190367
Device Name Smith & Nephew Tablet Application
Smith & Nephew
150 Minuteman Road
Andover,  MA  01810
Applicant Contact Janice Haselton
Smith & Nephew
150 Minuteman Road
Andover,  MA  01810
Correspondent Contact Janice Haselton
Regulation Number876.1500
Classification Product Code
Date Received02/15/2019
Decision Date 05/21/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No