Cleared Traditional

K864371 - SURGICAL SKIN MARKER
(FDA 510(k) Clearance)

K864371 · Myocure, Inc. · General & Plastic Surgery device

Nov 1986

Decision

12d

Days

Class 1

Risk

K864371 is an FDA 510(k) clearance for the SURGICAL SKIN MARKER. This device is classified as a Marker, Skin (Class I - General Controls, product code FZZ).

Submitted by Myocure, Inc. (Glendale, US). The FDA issued a Cleared decision on November 17, 1986, 12 days after receiving the submission on November 5, 1986.

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

Submission Details

510(k) Number	K864371 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 05, 1986
Decision Date	November 17, 1986
Days to Decision	12 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—