Cleared Traditional

TABLE, OPERATING, FIELD 6530-00-709-8175

K821923 · Emerson-Sack-Warner Corp. · General & Plastic Surgery
Jul 1982
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K821923 is an FDA 510(k) clearance for the TABLE, OPERATING, FIELD 6530-00-709-8175, a Table, Operating-room, Mechanical (Class I — General Controls, product code FWX), submitted by Emerson-Sack-Warner Corp. (Mchenry, US). The FDA issued a Cleared decision on July 13, 1982, 14 days after receiving the submission on June 29, 1982. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4950.

Submission Details

510(k) Number K821923 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 1982
Decision Date July 13, 1982
Days to Decision 14 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code FWX — Table, Operating-room, Mechanical
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4950