Cleared Traditional

K963506 - TENET RADIOLUCENT HAND TABLE
(FDA 510(k) Clearance)

K963506 · Tenet Medical Engineering · General & Plastic Surgery device

Jan 1997

Decision

128d

Days

Class 1

Risk

K963506 is an FDA 510(k) clearance for the TENET RADIOLUCENT HAND TABLE. This device is classified as a Table, Operating-room, Ac-powered (Class I - General Controls, product code FQO).

Submitted by Tenet Medical Engineering (Calgary, CA). The FDA issued a Cleared decision on January 9, 1997, 128 days after receiving the submission on September 3, 1996.

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

Submission Details

510(k) Number	K963506 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 03, 1996
Decision Date	January 09, 1997
Days to Decision	128 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement