Cleared Traditional

1.1 COUPLERS AND 1.2 ADAPTERS

K872550 · Micro-Aire Surgical Instruments, Inc. · Orthopedic

Jul 1987

Decision

22d

Days

Class 1

Risk

About This 510(k) Submission

K872550 is an FDA 510(k) clearance for the 1.1 COUPLERS AND 1.2 ADAPTERS, 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 July 21, 1987, 22 days after receiving the submission on June 29, 1987. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K872550 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 29, 1987
Decision Date	July 21, 1987
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