Uni-port— 510(k) K232062

Substantially Equivalent

Dalim Medical Corp.

FDA 510(k) clearance K232062 for Uni-port, Substantially Equivalent on 2024-01-16. Applicant: Dalim Medical Corp.. Device class: 2.

Clearance details

Applicant: Dalim Medical Corp.
Product code: Code OTJ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2023-07-11
Decision date: 2024-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bucheon-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.