DYNAMATRIX— 510(k) K082058

Substantially Equivalent

Cook Biotech, Inc.

FDA 510(k) clearance K082058 for DYNAMATRIX, Substantially Equivalent on 2008-10-02. Applicant: Cook Biotech, Inc.. Device class: 2.

Clearance details

Applicant: Cook Biotech, Inc.
Product code: Code NPL
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2008-07-21
Decision date: 2008-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.