SURGICAL HEADLIGHT— 510(k) K061690

Substantially Equivalent

Gulf Medical Fiberoptics

FDA 510(k) clearance K061690 for SURGICAL HEADLIGHT, Substantially Equivalent on 2006-09-15. Applicant: Gulf Medical Fiberoptics. Device class: 2.

Clearance details

Applicant: Gulf Medical Fiberoptics
Product code: Code FST
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2006-06-15
Decision date: 2006-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oldsmar, FL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.