Cleared Traditional

K951085 - PADGETT AIR DERMATOME, MODEL A
(FDA 510(k) Clearance)

K951085 · Padgett Instruments, Inc. · General & Plastic Surgery
May 1995
Decision
67d
Days
Class 1
Risk

K951085 is an FDA 510(k) clearance for the PADGETT AIR DERMATOME, MODEL A. This device is classified as a Dermatome (Class I — General Controls, product code GFD).

Submitted by Padgett Instruments, Inc. (Kansas City, US). The FDA issued a Cleared decision on May 15, 1995, 67 days after receiving the submission on March 9, 1995.

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

Submission Details

510(k) Number K951085 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 1995
Decision Date May 15, 1995
Days to Decision 67 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

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