SMARTO— 510(k) K101563

Substantially Equivalent

Jeil Medical Corporation

FDA 510(k) clearance K101563 for SMARTO, Substantially Equivalent on 2010-12-17. Applicant: Jeil Medical Corporation. Device class: 1.

Clearance details

Applicant: Jeil Medical Corporation
Product code: Code KIJ
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 2010-06-04
Decision date: 2010-12-17
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.