ENDOSCOPIC FIBEROPTIC CABLE— 510(k) K021931

Name: FDA 510(k) clearance K021931
Creator: U.S. Food and Drug Administration
Published: 2002-09-06

Substantially Equivalent

Gulf Medical Fiberoptics

FDA 510(k) clearance K021931 for ENDOSCOPIC FIBEROPTIC CABLE, Substantially Equivalent on 2002-09-06. Applicant: Gulf Medical Fiberoptics. Device class: 2.

Clearance details

Applicant: Gulf Medical Fiberoptics
Product code: Code HBI
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2002-06-12
Decision date: 2002-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oldsmar, FL, US

Download summary PDF View on FDA.gov ↗

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