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Found 1 results

510(k) Data Aggregation

K Number

Device Name

AVOGEL

Manufacturer

AVOCET POLYMER TECHNOLOGIES, INC.

Date Cleared

1999-06-01

(413 days)

Product Code

MDA, AVO

Regulation Number

878.4025

Why did this record match?

Applicant Name (Manufacturer) :

AVOCET POLYMER TECHNOLOGIES, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Avogel® is intended for use in the management of hypertrophic scars.

Device Description

Avogel® is a sheet of hydrogel with a polyurethane film backing.

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