MCCARTNEY ACCESS TUBE— 510(k) K051594

Substantially Equivalent

Gynetech Pty. , Ltd.

FDA 510(k) clearance K051594 for MCCARTNEY ACCESS TUBE, Substantially Equivalent on 2005-09-02. Applicant: Gynetech Pty. , Ltd.. Device class: 2.

Clearance details

Applicant: Gynetech Pty. , Ltd.
Product code: Code HEW
Device class: Class 2
Regulation: 21 CFR 884.1640
Advisory panel: Obstetrics/Gynecology
Date received: 2005-06-16
Decision date: 2005-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, 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.