TRACERS BONE CEMENT OPACIFIER— 510(k) K023445

Name: FDA 510(k) clearance K023445
Creator: U.S. Food and Drug Administration
Published: 2003-03-11

Substantially Equivalent

Parallax Medical, Inc.

FDA 510(k) clearance K023445 for TRACERS BONE CEMENT OPACIFIER, Substantially Equivalent on 2003-03-11. 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: 2002-10-15
Decision date: 2003-03-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Scotts Valley, CA, US

Download summary PDF View on FDA.gov ↗

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