AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS— 510(k) K062826

Name: FDA 510(k) clearance K062826
Creator: U.S. Food and Drug Administration
Published: 2007-05-22

Substantially Equivalent

Alpha-Omega Services, Inc.

FDA 510(k) clearance K062826 for AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS, Substantially Equivalent on 2007-05-22. Applicant: Alpha-Omega Services, Inc.. Device class: 2.

Clearance details

Applicant: Alpha-Omega Services, Inc.
Product code: Code JAQ
Device class: Class 2
Regulation: 21 CFR 892.5700
Advisory panel: Radiology
Date received: 2006-09-20
Decision date: 2007-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellflower, CA, US

Download summary PDF View on FDA.gov ↗

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K062824 — AOS UNIVERSAL CONECTING GUIDE TUBE2007-07-03
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Data sourced from openFDA. This site is unofficial and independent of the FDA.