Lum Vascular Procedure System #B5200A
FDA 510(k) K883664 · General Electric Co.
510(k) numberK883664
Submission
- Device name
- Lum Vascular Procedure System #B5200A
- Applicant
- General Electric Co.
Milwaukee, WI, US - Received
- August 26, 1988
- Decision date
- November 7, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Lum Vascular Procedure System #B5200A cleared by the FDA?
Lum Vascular Procedure System #B5200A (K883664) received a 510(k) decision of Substantially Equivalent on November 7, 1988, 73 days after the submission was received.
What is the product code of K883664?
The FDA product code is IYB – Tube Mount, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1770.