Cleared Traditional

K950192 - SKYTRON SKYBOOM SERIES
(FDA 510(k) Clearance)

K950192 · Skytron, Div. the Kmw Group, Inc. · General & Plastic Surgery

Apr 1995

Decision

75d

Days

Class 1

Risk

K950192 is an FDA 510(k) clearance for the SKYTRON SKYBOOM SERIES, a Table, Operating-room, Ac-powered (Class I — General Controls, product code FQO), submitted by Skytron, Div. the Kmw Group, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on April 3, 1995, 75 days after receiving the submission on January 18, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number	K950192 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 18, 1995
Decision Date	April 03, 1995
Days to Decision	75 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement