ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT— 510(k) K982865

Name: FDA 510(k) clearance K982865
Creator: U.S. Food and Drug Administration
Published: 1998-09-08

Substantially Equivalent

Atrix Laboratories, Inc.

FDA 510(k) clearance K982865 for ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT, Substantially Equivalent on 1998-09-08. Applicant: Atrix Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Atrix Laboratories, Inc.
Product code: Code NPK
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 1998-08-13
Decision date: 1998-09-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Fort Collins, CO, US

Download summary PDF View on FDA.gov ↗

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