AXXENT FLEXISHIELD MINI— 510(k) K090417

Substantially Equivalent

Xoft, Inc.

FDA 510(k) clearance K090417 for AXXENT FLEXISHIELD MINI, Substantially Equivalent on 2009-06-23. Applicant: Xoft, Inc.. Device class: 2.

Clearance details

Applicant: Xoft, Inc.
Product code: Code IXI
Device class: Class 2
Regulation: 21 CFR 892.5710
Advisory panel: Radiology
Date received: 2009-02-18
Decision date: 2009-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Xoft, Inc.

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Data sourced from openFDA. This site is unofficial and independent of the FDA.