PEAK NS033CF, PEAK NS017CF— 510(k) K180565

Substantially Equivalent

Neosil Co., Ltd.

FDA 510(k) clearance K180565 for PEAK NS033CF, PEAK NS017CF, Substantially Equivalent on 2018-06-13. Applicant: Neosil Co., Ltd.. Device class: 2.

Clearance details

Applicant: Neosil Co., Ltd.
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2018-03-05
Decision date: 2018-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gyeongsangnam-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.