N5-1— 510(k) K153054

Substantially Equivalent

Nuga Medical Co., Ltd.

FDA 510(k) clearance K153054 for N5-1, Substantially Equivalent on 2016-02-05. Applicant: Nuga Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Nuga Medical Co., Ltd.
Product code: Code JFB
Device class: Class 2
Regulation: 21 CFR 890.5880
Advisory panel: Physical Medicine
Date received: 2015-10-20
Decision date: 2016-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wonju-Si, 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.