Cleared Traditional

K894789 - DMI 250 SERIES POWER SURGERY TABLE
(FDA 510(k) Clearance)

K894789 · M.D. Intl., Inc. · General & Plastic Surgery

Aug 1989

Decision

32d

Days

Class 1

Risk

K894789 is an FDA 510(k) clearance for the DMI 250 SERIES POWER SURGERY TABLE, a Table, Surgical With Orthopedic Accessories, Ac-powered (Class I — General Controls, product code JEA), submitted by M.D. Intl., Inc. (Salt Lake City, US). The FDA issued a Cleared decision on August 29, 1989, 32 days after receiving the submission on July 28, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number	K894789 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 28, 1989
Decision Date	August 29, 1989
Days to Decision	32 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—