INTRAGen— 510(k) K142833

Substantially Equivalent

Jeisys Medical, Inc.

FDA 510(k) clearance K142833 for INTRAGen, Substantially Equivalent on 2015-06-04. Applicant: Jeisys Medical, Inc.. Device class: 2.

Clearance details

Applicant: Jeisys Medical, Inc.
Product code: Code OUH
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2014-09-30
Decision date: 2015-06-04
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.