LU-TEX II— 510(k) K904535

Substantially Equivalent

Lukens Medical Corp.

FDA 510(k) clearance K904535 for LU-TEX II, Substantially Equivalent on 1991-01-30. Applicant: Lukens Medical Corp.. Device class: 2.

Clearance details

Applicant: Lukens Medical Corp.
Product code: Code GAS
Device class: Class 2
Regulation: 21 CFR 878.5000
Advisory panel: General, Plastic Surgery
Date received: 1990-10-04
Decision date: 1991-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rio Rancho, NM, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.