Cleared Traditional

OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5

K872092 · Military Engineering, Inc. · General & Plastic Surgery
Jun 1987
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K872092 is an FDA 510(k) clearance for the OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5, a Chisel (osteotome) (Class I — General Controls, product code KDG), submitted by Military Engineering, Inc. (Plymouth, US). The FDA issued a Cleared decision on June 23, 1987, 22 days after receiving the submission on June 1, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number K872092 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 1987
Decision Date June 23, 1987
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