Cleared Traditional

K880324 - MICRO-AIRE CEMENT REMOVAL TOOLS
(FDA 510(k) Clearance)

K880324 · Micro-Aire Surgical Instruments, Inc. · Orthopedic

Feb 1988

Decision

22d

Days

Class 1

Risk

K880324 is an FDA 510(k) clearance for the MICRO-AIRE CEMENT REMOVAL TOOLS, a Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (Class I — General Controls, product code HSZ), submitted by Micro-Aire Surgical Instruments, Inc. (San Fernando, US). The FDA issued a Cleared decision on February 17, 1988, 22 days after receiving the submission on January 26, 1988. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K880324 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 26, 1988
Decision Date	February 17, 1988
Days to Decision	22 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

Device Classification

Product Code	HSZ — Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment
Device Class	Class I — General Controls
CFR Regulation	21 CFR 878.4820