Cleared Traditional

VISIONARY 2000

K000639 · Burton Medical Products Corp. · General & Plastic Surgery
May 2000
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K000639 is an FDA 510(k) clearance for the VISIONARY 2000, a Light, Surgical, Ceiling Mounted (Class II — Special Controls, product code FSY), submitted by Burton Medical Products Corp. (Chatsworth, US). The FDA issued a Cleared decision on May 25, 2000, 90 days after receiving the submission on February 25, 2000. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number K000639 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 2000
Decision Date May 25, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code FSY — Light, Surgical, Ceiling Mounted
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4580

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