Cleared Traditional

K900475 - DISTRAC(TM) TABLE
(FDA 510(k) Clearance)

K900475 · Lossing Orthopedic, Inc. · Physical Medicine

May 1990

Decision

112d

Days

Class 2

Risk

K900475 is an FDA 510(k) clearance for the DISTRAC(TM) TABLE, a Equipment, Traction, Powered (Class II — Special Controls, product code ITH), submitted by Lossing Orthopedic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 24, 1990, 112 days after receiving the submission on February 1, 1990. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5900.

Submission Details

510(k) Number	K900475 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 1990
Decision Date	May 24, 1990
Days to Decision	112 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—