Cleared Traditional

ALM OPERATING TABLES

K884019 · Alm Surgical Equipment, Inc. · General & Plastic Surgery
Oct 1988
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K884019 is an FDA 510(k) clearance for the ALM OPERATING TABLES, a Table, Operating-room, Mechanical (Class I — General Controls, product code FWX), submitted by Alm Surgical Equipment, Inc. (Santa Ana, US). The FDA issued a Cleared decision on October 13, 1988, 21 days after receiving the submission on September 22, 1988. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4950.

Submission Details

510(k) Number K884019 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 1988
Decision Date October 13, 1988
Days to Decision 21 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