Cleared Traditional

K940208 - AESCULAP ACCU-DERMATOME
(FDA 510(k) Clearance)

K940208 · Aesculap, Inc. · General & Plastic Surgery
Feb 1994
Decision
41d
Days
Class 1
Risk

K940208 is an FDA 510(k) clearance for the AESCULAP ACCU-DERMATOME, a Dermatome (Class I — General Controls, product code GFD), submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on February 24, 1994, 41 days after receiving the submission on January 14, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number K940208 FDA.gov
FDA Decision Cleared SESE
Date Received January 14, 1994
Decision Date February 24, 1994
Days to Decision 41 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

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