Cleared Traditional

K861285 - SKIN MESH DEVICE
(FDA 510(k) Clearance)

K861285 · Precision Modified Devices · General & Plastic Surgery
Apr 1986
Decision
10d
Days
Class 1
Risk

K861285 is an FDA 510(k) clearance for the SKIN MESH DEVICE, a Dermatome (Class I — General Controls, product code GFD), submitted by Precision Modified Devices (Salt Lake City, US). The FDA issued a Cleared decision on April 17, 1986, 10 days after receiving the submission on April 7, 1986. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number K861285 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 1986
Decision Date April 17, 1986
Days to Decision 10 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GFD — Dermatome
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4820