Dmi 250 Series Power Surgery Table

FDA 510(k) K894789 · M.D. Intl., Inc.

Substantially Equivalent

510(k) numberK894789

Submission

Device name
Dmi 250 Series Power Surgery Table
Applicant
M.D. Intl., Inc.
Salt Lake City, UT, US
Received
July 28, 1989
Decision date
August 29, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JEA – Table, Surgical With Orthopedic Accessories, Ac-Powered
Device class
Class I (low risk)
Regulation
21 CFR 878.4960
Specialty
General, Plastic Surgery

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K900290Skytron Model 1100 and Model 142JEA · Traditional Skytron, Div. the Kmw Group, Inc.02/20/1990SE
K881060Osi Rizzoli Trauma Table (Electric Version)JEA · Traditional Orthopedic Systems, Inc.03/25/1988SE
K874762Arthrotract Upper Limb Traction AccessoryJEA · Traditional Andronic Devices, Ltd.12/10/1987SE
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K873079Arthrobot 100 Upper Limb PositionerJEA · Traditional Andronic Devices, Ltd.11/25/1987SE

More from Andronic Devices, Ltd.

510(k)DeviceDecision
K894788Dmi Series 90 Examination TableKMN · Traditional 09/08/1989SE
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Questions and answers

When was Dmi 250 Series Power Surgery Table cleared by the FDA?

Dmi 250 Series Power Surgery Table (K894789) received a 510(k) decision of Substantially Equivalent on August 29, 1989, 32 days after the submission was received.

What is the product code of K894789?

The FDA product code is JEA – Table, Surgical With Orthopedic Accessories, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4960.