Cleared Traditional

K874503 - MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER
(FDA 510(k) Clearance)

K874503 · Micro-Aire Surgical Instruments, Inc. · General & Plastic Surgery
Dec 1987
Decision
30d
Days
Class 1
Risk

K874503 is an FDA 510(k) clearance for the MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER, a Osteotome (Class I — General Controls, product code HWM), submitted by Micro-Aire Surgical Instruments, Inc. (San Fernando, US). The FDA issued a Cleared decision on December 2, 1987, 30 days after receiving the submission on November 2, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K874503 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 1987
Decision Date December 02, 1987
Days to Decision 30 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code HWM — Osteotome
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800