10PL— 510(k) K220794

Substantially Equivalent

Tentech Co. , Ltd.

FDA 510(k) clearance K220794 for 10PL, Substantially Equivalent on 2022-11-10. Applicant: Tentech Co. , Ltd.. Device class: 2.

Clearance details

Applicant: Tentech Co. , Ltd.
Product code: Code ONF
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2022-03-18
Decision date: 2022-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gangnam-Gu, 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.