PEN, MARK-3 SKIN MARKING FOUNTAIN— 510(k) K781694

Name: FDA 510(k) clearance K781694
Creator: U.S. Food and Drug Administration
Published: 1978-12-04

Substantially Equivalent

Omega Mark-3 Pen Corp.

FDA 510(k) clearance K781694 for PEN, MARK-3 SKIN MARKING FOUNTAIN, Substantially Equivalent on 1978-12-04. Applicant: Omega Mark-3 Pen Corp.. Device class: 1.

Clearance details

Applicant: Omega Mark-3 Pen Corp.
Product code: Code FZZ
Device class: Class 1
Regulation: 21 CFR 878.4660
Advisory panel: General, Plastic Surgery
Date received: 1978-10-10
Decision date: 1978-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.