FITme Customized Silicone Implant— 510(k) K232593

Name: FDA 510(k) clearance K232593
Creator: U.S. Food and Drug Administration
Published: 2023-11-22

Substantially Equivalent

Keosan Trading Co.

FDA 510(k) clearance K232593 for FITme Customized Silicone Implant, Substantially Equivalent on 2023-11-22. Applicant: Keosan Trading Co.. Device class: 2.

Clearance details

Applicant: Keosan Trading Co.
Product code: Code FWP
Device class: Class 2
Regulation: 21 CFR 878.3550
Advisory panel: General, Plastic Surgery
Date received: 2023-08-25
Decision date: 2023-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, 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.