GYNECOLOGY STERILIZATION TRAY— 510(k) K121904

Name: FDA 510(k) clearance K121904
Creator: U.S. Food and Drug Administration
Published: 2013-03-11

Substantially Equivalent

Smith & Nephew Inc., Endoscopy Division

FDA 510(k) clearance K121904 for GYNECOLOGY STERILIZATION TRAY, Substantially Equivalent on 2013-03-11. Applicant: Smith & Nephew Inc., Endoscopy Division. Device class: 2.

Clearance details

Applicant: Smith & Nephew Inc., Endoscopy Division
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2012-06-29
Decision date: 2013-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

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