Cleared Traditional

K914758 - MDT/SHAMPAINE MODEL 4900B SURGICAL TABLE
(FDA 510(k) Clearance)

K914758 · Mdt Corp., Inc. · General & Plastic Surgery
Dec 1991
Decision
58d
Days
Class 1
Risk

K914758 is an FDA 510(k) clearance for the MDT/SHAMPAINE MODEL 4900B SURGICAL TABLE. This device is classified as a Table, Operating-room, Electrical (Class I — General Controls, product code GDC).

Submitted by Mdt Corp., Inc. (Rochester, US). The FDA issued a Cleared decision on December 19, 1991, 58 days after receiving the submission on October 22, 1991.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number K914758 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 1991
Decision Date December 19, 1991
Days to Decision 58 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code GDC — Table, Operating-room, Electrical
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4960

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