Tablet Application— 510(k) K203566

Substantially Equivalent

Smith & Nephew

FDA 510(k) clearance K203566 for Tablet Application, Substantially Equivalent on 2021-05-13. Applicant: Smith & Nephew. Device class: 2.

Clearance details

Applicant: Smith & Nephew
Product code: Code ODA
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2020-12-07
Decision date: 2021-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.