Cleared Traditional

WAVE FLUORESCENT MAGNIFIER

K936088 · Burton Medical Products Corp. · General Hospital
Apr 1994
Decision
126d
Days
Class 1
Risk

About This 510(k) Submission

K936088 is an FDA 510(k) clearance for the WAVE FLUORESCENT MAGNIFIER, a Device, Medical Examination, Ac Powered (Class I — General Controls, product code KZF), submitted by Burton Medical Products Corp. (Van Nuys, US). The FDA issued a Cleared decision on April 26, 1994, 126 days after receiving the submission on December 21, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6320.

Submission Details

510(k) Number K936088 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 1993
Decision Date April 26, 1994
Days to Decision 126 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code KZF — Device, Medical Examination, Ac Powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6320

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