Cleared Traditional

HYDRAULIC FOOT OPERATED STOOL

K893598 · Arthro-Medic, Inc. · General & Plastic Surgery
Oct 1989
Decision
154d
Days
Class 1
Risk

About This 510(k) Submission

K893598 is an FDA 510(k) clearance for the HYDRAULIC FOOT OPERATED STOOL, a Chair, Surgical, Ac-powered (Class I — General Controls, product code GBB), submitted by Arthro-Medic, Inc. (Jacksonville, US). The FDA issued a Cleared decision on October 10, 1989, 154 days after receiving the submission on May 9, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number K893598 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 1989
Decision Date October 10, 1989
Days to Decision 154 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code GBB — Chair, Surgical, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4960