RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12)— 510(k) K093508

Name: FDA 510(k) clearance K093508
Creator: U.S. Food and Drug Administration
Published: 2010-03-04

Substantially Equivalent

Womancare Global

FDA 510(k) clearance K093508 for RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12), Substantially Equivalent on 2010-03-04. Applicant: Womancare Global. Device class: 2.

Clearance details

Applicant: Womancare Global
Product code: Code HGH
Device class: Class 2
Regulation: 21 CFR 884.5070
Advisory panel: Obstetrics/Gynecology
Date received: 2009-11-12
Decision date: 2010-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chapel Hill, NC, US

Download summary PDF View on FDA.gov ↗

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