LUM VASCULAR PROCEDURE SYSTEM #B5200A— 510(k) K883664

Name: FDA 510(k) clearance K883664
Creator: U.S. Food and Drug Administration
Published: 1988-11-07

Substantially Equivalent

General Electric Co.

FDA 510(k) clearance K883664 for LUM VASCULAR PROCEDURE SYSTEM #B5200A, Substantially Equivalent on 1988-11-07. Applicant: General Electric Co.. Device class: 1.

Clearance details

Applicant: General Electric Co.
Product code: Code IYB
Device class: Class 1
Regulation: 21 CFR 892.1770
Advisory panel: Radiology
Date received: 1988-08-26
Decision date: 1988-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

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