VONFLEX S BITE— 510(k) K140966

Substantially Equivalent

Vericom Co., Ltd.

FDA 510(k) clearance K140966 for VONFLEX S BITE, Substantially Equivalent on 2014-08-15. Applicant: Vericom Co., Ltd.. Device class: 2.

Clearance details

Applicant: Vericom Co., Ltd.
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2014-04-15
Decision date: 2014-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chuncheon-Si, Gangwon - Do, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.