Cleared Traditional

DISPOSABLE SKIN MARKER

K915066 · American Medical Mfg., Inc. · General & Plastic Surgery
May 1992
Decision
188d
Days
Class 1
Risk

About This 510(k) Submission

K915066 is an FDA 510(k) clearance for the DISPOSABLE SKIN MARKER, a Marker, Skin (Class I — General Controls, product code FZZ), submitted by American Medical Mfg., Inc. (Calabasas, US). The FDA issued a Cleared decision on May 14, 1992, 188 days after receiving the submission on November 8, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4660.

Submission Details

510(k) Number K915066 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 1991
Decision Date May 14, 1992
Days to Decision 188 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code FZZ — Marker, Skin
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4660