Cleared Traditional

K904559 - QUALTEX SKIN MARKER
(FDA 510(k) Clearance)

K904559 · Qualtex, Inc. · General & Plastic Surgery device

Dec 1990

Decision

69d

Days

Class 1

Risk

K904559 is an FDA 510(k) clearance for the QUALTEX SKIN MARKER. This device is classified as a Marker, Skin (Class I - General Controls, product code FZZ).

Submitted by Qualtex, Inc. (Knoxville, US). The FDA issued a Cleared decision on December 13, 1990, 69 days after receiving the submission on October 5, 1990.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4660.

Submission Details

510(k) Number	K904559 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 05, 1990
Decision Date	December 13, 1990
Days to Decision	69 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—