Cleared Traditional

CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE

K981962 · Cuda Products Co. · General & Plastic Surgery
Aug 1998
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K981962 is an FDA 510(k) clearance for the CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE, a Light, Surgical, Floor Standing (Class II — Special Controls, product code FSS), submitted by Cuda Products Co. (Jacksonville, US). The FDA issued a Cleared decision on August 18, 1998, 75 days after receiving the submission on June 4, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number K981962 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 1998
Decision Date August 18, 1998
Days to Decision 75 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code FSS — Light, Surgical, Floor Standing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4580

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