Cleared Traditional

FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS

K822265 · Kelleher Corp. · Dental
Sep 1982
Decision
61d
Days
Class 1
Risk

About This 510(k) Submission

K822265 is an FDA 510(k) clearance for the FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS, a Light, Surgical Headlight (Class I — General Controls, product code EBA), submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on September 28, 1982, 61 days after receiving the submission on July 29, 1982. This device falls under the Dental review panel. Regulated under 21 CFR 872.4630.

Submission Details

510(k) Number K822265 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 1982
Decision Date September 28, 1982
Days to Decision 61 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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