Cleared Traditional

K792332 - DAVOL/SIMON DERMATOME (FDA 510(k) Clearance)

Dec 1979
Decision
17d
Days
Class 1
Risk

K792332 is an FDA 510(k) clearance for the DAVOL/SIMON DERMATOME. This device is classified as a Dermatome (Class I - General Controls, product code GFD).

Submitted by Davol, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 6, 1979, 17 days after receiving the submission on November 19, 1979.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number K792332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1979
Decision Date December 06, 1979
Days to Decision 17 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