Cleared Traditional

SURGICAL CHISEL/OSTEOTOME

K894785 · Fdt Precision Machine Co., Inc. · General & Plastic Surgery
Aug 1989
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K894785 is an FDA 510(k) clearance for the SURGICAL CHISEL/OSTEOTOME, a Chisel (osteotome) (Class I — General Controls, product code KDG), submitted by Fdt Precision Machine Co., Inc. (Bridgeport, US). The FDA issued a Cleared decision on August 18, 1989, 22 days after receiving the submission on July 27, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number K894785 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 1989
Decision Date August 18, 1989
Days to Decision 22 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code KDG — Chisel (osteotome)
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4820