ZIRMON SERIES— 510(k) K131117

Substantially Equivalent

Kuwotech Co., Ltd.

FDA 510(k) clearance K131117 for ZIRMON SERIES, Substantially Equivalent on 2013-07-26. Applicant: Kuwotech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Kuwotech Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2013-04-22
Decision date: 2013-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, 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.