ORMCO SYSTEM 1+ (TM)— 510(k) K941015

Substantially Equivalent

Ormco Corp.

FDA 510(k) clearance K941015 for ORMCO SYSTEM 1+ (TM), Substantially Equivalent on 1994-03-31. Applicant: Ormco Corp.. Device class: 2.

Clearance details

Applicant: Ormco Corp.
Product code: Code DYH
Device class: Class 2
Regulation: 21 CFR 872.3750
Advisory panel: Dental
Date received: 1994-03-03
Decision date: 1994-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendora, 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.