SLIMUS— 510(k) K192970

Substantially Equivalent

Hironic Co., Ltd.

FDA 510(k) clearance K192970 for SLIMUS, Substantially Equivalent on 2020-12-01. Applicant: Hironic Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hironic Co., Ltd.
Product code: Code PKT
Device class: Class 2
Regulation: 21 CFR 878.5400
Advisory panel: General, Plastic Surgery
Date received: 2019-10-23
Decision date: 2020-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yongin-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.