ENDO A CLASS— 510(k) K123582

Substantially Equivalent

Saeyang Microtech Co., Ltd.

FDA 510(k) clearance K123582 for ENDO A CLASS, Substantially Equivalent on 2013-08-16. Applicant: Saeyang Microtech Co., Ltd.. Device class: 1.

Clearance details

Applicant: Saeyang Microtech Co., Ltd.
Product code: Code EKX
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2012-11-20
Decision date: 2013-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, 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.