AURA— 510(k) K102984

Substantially Equivalent

Sdi Limited

FDA 510(k) clearance K102984 for AURA, Substantially Equivalent on 2010-12-08. Applicant: Sdi Limited. Device class: 2.

Clearance details

Applicant: Sdi Limited
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2010-10-07
Decision date: 2010-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bayswater, AU

Download summary PDF View on FDA.gov ↗

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