Cleared Traditional

CUDA SURGICAL LIGHT

K901491 · Cuda Products Co. · General & Plastic Surgery
Jun 1990
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K901491 is an FDA 510(k) clearance for the CUDA SURGICAL LIGHT, 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 June 18, 1990, 81 days after receiving the submission on March 29, 1990. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number K901491 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 1990
Decision Date June 18, 1990
Days to Decision 81 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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