INSIGNIA— 510(k) K121524

Substantially Equivalent

Ormco Corp.

FDA 510(k) clearance K121524 for INSIGNIA, Substantially Equivalent on 2012-08-09. Applicant: Ormco Corp.. Device class: 2.

Clearance details

Applicant: Ormco Corp.
Product code: Code DYW
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2012-05-23
Decision date: 2012-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, 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.