Cleared Traditional

K962371 - DERMTOME BLADE
(FDA 510(k) Clearance)

K962371 · Dsp Worldwide · General & Plastic Surgery
Aug 1996
Decision
71d
Days
Class 1
Risk

K962371 is an FDA 510(k) clearance for the DERMTOME BLADE, a Dermatome (Class I — General Controls, product code GFD), submitted by Dsp Worldwide (North Attleboro, US). The FDA issued a Cleared decision on August 29, 1996, 71 days after receiving the submission on June 19, 1996. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number K962371 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 1996
Decision Date August 29, 1996
Days to Decision 71 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