Cleared Traditional

K841360 - MINOR SURGICAL LIGHT MODEL 180
(FDA 510(k) Clearance)

Apr 1984
Decision
22d
Days
Class 2
Risk

K841360 is an FDA 510(k) clearance for the MINOR SURGICAL LIGHT MODEL 180. This device is classified as a Lamp, Surgical (Class II - Special Controls, product code FTD).

Submitted by American Sterilizer Co. (Mchenry, US). The FDA issued a Cleared decision on April 24, 1984, 22 days after receiving the submission on April 2, 1984.

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

Submission Details

510(k) Number K841360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1984
Decision Date April 24, 1984
Days to Decision 22 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code FTD — Lamp, Surgical
Device Class Class II - Special Controls
CFR Regulation 21 CFR 878.4580