Cleared Traditional

K900290 - SKYTRON MODEL 1100 AND MODEL 142
(FDA 510(k) Clearance)

K900290 · Skytron, Div. the Kmw Group, Inc. · General & Plastic Surgery

Feb 1990

Decision

29d

Days

Class 1

Risk

K900290 is an FDA 510(k) clearance for the SKYTRON MODEL 1100 AND MODEL 142, a Table, Surgical With Orthopedic Accessories, Ac-powered (Class I — General Controls, product code JEA), submitted by Skytron, Div. the Kmw Group, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on February 20, 1990, 29 days after receiving the submission on January 22, 1990. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number	K900290 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 22, 1990
Decision Date	February 20, 1990
Days to Decision	29 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—