Cleared Traditional

GENIE

K961843 · Burton Medical Products Corp. · General & Plastic Surgery
Aug 1996
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K961843 is an FDA 510(k) clearance for the GENIE, 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 August 22, 1996, 101 days after receiving the submission on May 13, 1996. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number K961843 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 1996
Decision Date August 22, 1996
Days to Decision 101 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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