POWERTOME PERIOTOME— 510(k) K063007

Substantially Equivalent

Westport Medical, Inc.

FDA 510(k) clearance K063007 for POWERTOME PERIOTOME, Substantially Equivalent on 2006-10-17. Applicant: Westport Medical, Inc.. Device class: 1.

Clearance details

Applicant: Westport Medical, Inc.
Product code: Code EKX
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2006-10-02
Decision date: 2006-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salem, OR, 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.