Cleared Traditional

MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300

K893491 · Cuda Products Co. · General & Plastic Surgery
Jun 1989
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K893491 is an FDA 510(k) clearance for the MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300, 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 22, 1989, 49 days after receiving the submission on May 4, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number K893491 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 1989
Decision Date June 22, 1989
Days to Decision 49 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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