ULTRA LOW PROFILE RONGEUR— 510(k) K062711

Substantially Equivalent

Baxano, Inc.

FDA 510(k) clearance K062711 for ULTRA LOW PROFILE RONGEUR, Substantially Equivalent on 2007-03-07. 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: 2006-09-11
Decision date: 2007-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yorba Linda, 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.