Cleared Traditional

SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG

K941869 · The Lighthouse For the Blind, Inc. · General Hospital

Aug 1994

Decision

107d

Days

Class 1

Risk

About This 510(k) Submission

K941869 is an FDA 510(k) clearance for the SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG, a Device, Medical Examination, Ac Powered (Class I — General Controls, product code KZF), submitted by The Lighthouse For the Blind, Inc. (Seattle, US). The FDA issued a Cleared decision on August 3, 1994, 107 days after receiving the submission on April 18, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6320.

Submission Details

510(k) Number	K941869 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 18, 1994
Decision Date	August 03, 1994
Days to Decision	107 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF