Cleared Traditional

FIBEROPTIC HEADLIGHT SYSTEM

K893458 · Cuda Products Co. · Dental
Jun 1989
Decision
51d
Days
Class 1
Risk

About This 510(k) Submission

K893458 is an FDA 510(k) clearance for the FIBEROPTIC HEADLIGHT SYSTEM, a Light, Surgical Headlight (Class I — General Controls, product code EBA), submitted by Cuda Products Co. (Jacksonville, US). The FDA issued a Cleared decision on June 22, 1989, 51 days after receiving the submission on May 2, 1989. This device falls under the Dental review panel. Regulated under 21 CFR 872.4630.

Submission Details

510(k) Number K893458 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 1989
Decision Date June 22, 1989
Days to Decision 51 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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