Cleared Traditional

K900175 - 4/1 ARMBOARD
(FDA 510(k) Clearance)

K900175 · Infection Control Products, Inc. · General & Plastic Surgery device

Jan 1990

Decision

12d

Days

Class 1

Risk

K900175 is an FDA 510(k) clearance for the 4/1 ARMBOARD. This device is classified as a Board, Arm (with Cover), Sterile (Class I - General Controls, product code BTX).

Submitted by Infection Control Products, Inc. (Gardendale, US). The FDA issued a Cleared decision on January 24, 1990, 12 days after receiving the submission on January 12, 1990.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3910.

Submission Details

510(k) Number	K900175 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 12, 1990
Decision Date	January 24, 1990
Days to Decision	12 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—