QUALTEX SKIN MARKER— 510(k) K904559

Substantially Equivalent

Qualtex, Inc.

FDA 510(k) clearance K904559 for QUALTEX SKIN MARKER, Substantially Equivalent on 1990-12-13. Applicant: Qualtex, Inc.. Device class: 1.

Clearance details

Applicant: Qualtex, Inc.
Product code: Code FZZ
Device class: Class 1
Regulation: 21 CFR 878.4660
Advisory panel: General, Plastic Surgery
Date received: 1990-10-05
Decision date: 1990-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Powell, TN, US

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