ULTRASONIC SURGERY MACHINE— 510(k) K113152

Substantially Equivalent

Dmetec.Co., Ltd.

FDA 510(k) clearance K113152 for ULTRASONIC SURGERY MACHINE, Substantially Equivalent on 2012-06-14. Applicant: Dmetec.Co., Ltd.. Device class: 2.

Clearance details

Applicant: Dmetec.Co., Ltd.
Product code: Code DZI
Device class: Class 2
Regulation: 21 CFR 872.4120
Advisory panel: Dental
Date received: 2011-10-25
Decision date: 2012-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendale, 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.