CONCERT CRANIOPLAST— 510(k) K023575

Substantially Equivalent

Immedica, Inc.

FDA 510(k) clearance K023575 for CONCERT CRANIOPLAST, Substantially Equivalent on 2003-01-22. Applicant: Immedica, Inc.. Device class: 2.

Clearance details

Applicant: Immedica, Inc.
Product code: Code GXP
Device class: Class 2
Regulation: 21 CFR 882.5300
Advisory panel: Neurology
Date received: 2002-10-24
Decision date: 2003-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.