Cleared Traditional

K882333 - FLOOR LIGHT
(FDA 510(k) Clearance)

K882333 · Commercial Products & Engineering Co. · General & Plastic Surgery

Jun 1988

Decision

17d

Days

Class 2

Risk

K882333 is an FDA 510(k) clearance for the FLOOR LIGHT. This device is classified as a Light, Surgical, Floor Standing (Class II — Special Controls, product code FSS).

Submitted by Commercial Products & Engineering Co. (Grand Rapids, US). The FDA issued a Cleared decision on June 23, 1988, 17 days after receiving the submission on June 6, 1988.

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

Submission Details

510(k) Number	K882333 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 06, 1988
Decision Date	June 23, 1988
Days to Decision	17 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—