MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES— 510(k) K100958

Name: FDA 510(k) clearance K100958
Creator: U.S. Food and Drug Administration
Published: 2010-07-23

Substantially Equivalent

Baxano, Inc.

FDA 510(k) clearance K100958 for MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES, Substantially Equivalent on 2010-07-23. Applicant: Baxano, Inc.. Device class: 2.

Clearance details

Applicant: Baxano, Inc.
Product code: Code HAE
Device class: Class 2
Regulation: 21 CFR 882.4840
Advisory panel: Neurology
Date received: 2010-04-07
Decision date: 2010-07-23
Decision: Substantially Equivalent
Clearance type: Special
Location: San Jose, CA, 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.