MODEL 0450000, OPAL MEDICAL EXAM LIGHT— 510(k) K893808

Name: FDA 510(k) clearance K893808
Creator: U.S. Food and Drug Administration
Published: 1989-08-15

Substantially Equivalent

Burton Medical Products Corp.

FDA 510(k) clearance K893808 for MODEL 0450000, OPAL MEDICAL EXAM LIGHT, Substantially Equivalent on 1989-08-15. Applicant: Burton Medical Products Corp.. Device class: 1.

Clearance details

Applicant: Burton Medical Products Corp.
Product code: Code KZF
Device class: Class 1
Regulation: 21 CFR 880.6320
Advisory panel: General Hospital
Date received: 1989-05-22
Decision date: 1989-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Van Nuys, CA, US

Download summary PDF View on FDA.gov ↗

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