Cleared Traditional

K940068 - STRYKER OPERATING ROOM TABLE
(FDA 510(k) Clearance)

K940068 · Stryker Medical · General & Plastic Surgery device

May 1994

Decision

119d

Days

Class 1

Risk

K940068 is an FDA 510(k) clearance for the STRYKER OPERATING ROOM TABLE. This device is classified as a Table, Operating-room, Ac-powered (Class I - General Controls, product code FQO).

Submitted by Stryker Medical (Kalamazoo, US). The FDA issued a Cleared decision on May 5, 1994, 119 days after receiving the submission on January 6, 1994.

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

Submission Details

510(k) Number	K940068 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 06, 1994
Decision Date	May 05, 1994
Days to Decision	119 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement