AVOGEL— 510(k) K981353

Substantially Equivalent

Avocet Polymer Technologies, Inc.

FDA 510(k) clearance K981353 for AVOGEL, Substantially Equivalent on 1999-06-01. Applicant: Avocet Polymer Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Avocet Polymer Technologies, Inc.
Product code: Code MDA
Device class: Class 1
Regulation: 21 CFR 878.4025
Advisory panel: General, Plastic Surgery
Date received: 1998-04-14
Decision date: 1999-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntsville, AL, 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.