DEFENDO Y-OPSY IRRIGATOR— 510(k) K110088

Name: FDA 510(k) clearance K110088
Creator: U.S. Food and Drug Administration
Published: 2011-06-10

Substantially Equivalent

Byrne Medical Incorporated

FDA 510(k) clearance K110088 for DEFENDO Y-OPSY IRRIGATOR, Substantially Equivalent on 2011-06-10. Applicant: Byrne Medical Incorporated. Device class: 2.

Clearance details

Applicant: Byrne Medical Incorporated
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2011-01-12
Decision date: 2011-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Conroe, TX, US

Download summary PDF View on FDA.gov ↗

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