Cleared Traditional

OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305

K903650 · Micro-Aire Surgical Instruments, Inc. · Orthopedic

Sep 1990

Decision

32d

Days

Class 1

Risk

About This 510(k) Submission

K903650 is an FDA 510(k) clearance for the OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305, a Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (Class I — General Controls, product code HWE), submitted by Micro-Aire Surgical Instruments, Inc. (Valencia, US). The FDA issued a Cleared decision on September 14, 1990, 32 days after receiving the submission on August 13, 1990. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K903650 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 13, 1990
Decision Date	September 14, 1990
Days to Decision	32 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

Device Classification

Product Code	HWE — Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
Device Class	Class I — General Controls
CFR Regulation	21 CFR 878.4820