Cleared Traditional

HALOGEN HEADLIGHT SYSTEM

K810117 · Colmed, Ltd. · Dental
Feb 1981
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K810117 is an FDA 510(k) clearance for the HALOGEN HEADLIGHT SYSTEM, a Light, Surgical Headlight (Class I — General Controls, product code EBA), submitted by Colmed, Ltd. (Mchenry, US). The FDA issued a Cleared decision on February 10, 1981, 25 days after receiving the submission on January 16, 1981. This device falls under the Dental review panel. Regulated under 21 CFR 872.4630.

Submission Details

510(k) Number K810117 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 1981
Decision Date February 10, 1981
Days to Decision 25 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EBA — Light, Surgical Headlight
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4630

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