DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305— 510(k) K102581

Name: FDA 510(k) clearance K102581
Creator: U.S. Food and Drug Administration
Published: 2010-11-08

Substantially Equivalent

Byrne Medical, Inc.

FDA 510(k) clearance K102581 for DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305, Substantially Equivalent on 2010-11-08. Applicant: Byrne Medical, Inc.. Device class: 2.

Clearance details

Applicant: Byrne Medical, Inc.
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2010-09-08
Decision date: 2010-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Conroe, TX, US

Download summary PDF View on FDA.gov ↗

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