Cleared Traditional

MOBILE OPHTHALMIC OPERATING TABLE

K841116 · Surgi-Quip Inc.U · General & Plastic Surgery
May 1984
Decision
55d
Days
Class 1
Risk

About This 510(k) Submission

K841116 is an FDA 510(k) clearance for the MOBILE OPHTHALMIC OPERATING TABLE, a Table, Operating-room, Mechanical (Class I — General Controls, product code FWX), submitted by Surgi-Quip Inc.U (Walker, US). The FDA issued a Cleared decision on May 9, 1984, 55 days after receiving the submission on March 15, 1984. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4950.

Submission Details

510(k) Number K841116 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 1984
Decision Date May 09, 1984
Days to Decision 55 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