Smith & Nephew Tablet Application— 510(k) K190367

Name: FDA 510(k) clearance K190367
Creator: U.S. Food and Drug Administration
Published: 2019-05-21

Substantially Equivalent

Smith & Nephew

FDA 510(k) clearance K190367 for Smith & Nephew Tablet Application, Substantially Equivalent on 2019-05-21. Applicant: Smith & Nephew. Device class: 2.

Clearance details

Applicant: Smith & Nephew
Product code: Code QGY
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2019-02-15
Decision date: 2019-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

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