Cleared Traditional

K930897 - MI-15 EXAM SURGICAL LIGHT
(FDA 510(k) Clearance)

K930897 · Medical Illumination, Inc. · General & Plastic Surgery device

Jun 1993

Decision

123d

Days

Class 2

Risk

K930897 is an FDA 510(k) clearance for the MI-15 EXAM SURGICAL LIGHT. This device is classified as a Lamp, Surgical (Class II - Special Controls, product code FTD).

Submitted by Medical Illumination, Inc. (Arleta, US). The FDA issued a Cleared decision on June 25, 1993, 123 days after receiving the submission on February 22, 1993.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number	K930897 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 22, 1993
Decision Date	June 25, 1993
Days to Decision	123 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement