SURGISIS GUIDED TISSUE REGENERATION MATRIX— 510(k) K010952

Name: FDA 510(k) clearance K010952
Creator: U.S. Food and Drug Administration
Published: 2002-06-10

Substantially Equivalent

Cook Biotech, Inc.

FDA 510(k) clearance K010952 for SURGISIS GUIDED TISSUE REGENERATION MATRIX, Substantially Equivalent on 2002-06-10. 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: 2001-03-30
Decision date: 2002-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Lafayette, IN, US

Download summary PDF View on FDA.gov ↗

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