PARALLAX TRACER RADIOPAQUE PARTICLES— 510(k) K991893

Name: FDA 510(k) clearance K991893
Creator: U.S. Food and Drug Administration
Published: 1999-08-13

Substantially Equivalent

Parallax Medical, Inc.

FDA 510(k) clearance K991893 for PARALLAX TRACER RADIOPAQUE PARTICLES, Substantially Equivalent on 1999-08-13. Applicant: Parallax Medical, Inc.. Device class: 2.

Clearance details

Applicant: Parallax Medical, Inc.
Product code: Code MYU
Device class: Class 2
Regulation: 21 CFR 882.5300
Advisory panel: Neurology
Date received: 1999-06-03
Decision date: 1999-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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