Cleared Traditional

OPERATING ROOM STAND

K840027 · Healthmate, Inc. · General & Plastic Surgery

Feb 1984

Decision

30d

Days

Class 1

Risk

About This 510(k) Submission

K840027 is an FDA 510(k) clearance for the OPERATING ROOM STAND, a Table, Operating-room, Manual (Class I — General Controls, product code FSE), submitted by Healthmate, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984, 30 days after receiving the submission on January 5, 1984. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4950.

Submission Details

510(k) Number	K840027 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 05, 1984
Decision Date	February 04, 1984
Days to Decision	30 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—