Cleared Traditional

FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE

K901035 · Cuda Products Co. · General & Plastic Surgery
Apr 1990
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K901035 is an FDA 510(k) clearance for the FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE, a Light, Surgical, Fiberoptic (Class II — Special Controls, product code FST), submitted by Cuda Products Co. (Jacksonville, US). The FDA issued a Cleared decision on April 23, 1990, 48 days after receiving the submission on March 6, 1990. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number K901035 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 1990
Decision Date April 23, 1990
Days to Decision 48 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code FST — Light, Surgical, Fiberoptic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4580

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