ORTHOGUARD AB ANTIMICROBIAL SLEEVE— 510(k) K022676

Name: FDA 510(k) clearance K022676
Creator: U.S. Food and Drug Administration
Published: 2002-09-23

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K022676 for ORTHOGUARD AB ANTIMICROBIAL SLEEVE, Substantially Equivalent on 2002-09-23. Applicant: Smith & Nephew, Inc.. Device class: 2.

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code JEC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2002-08-12
Decision date: 2002-09-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Memphis, TN, 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.