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FDA 510(k)

AVOGEL

K-Number: K981353 · 1999-06-01

ApplicantAvocet Polymer Technologies, Inc.
Decision Date1999-06-01
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AVOGEL is the device name listed in this FDA 510(k) record. The listed applicant is Avocet Polymer Technologies, Inc.. It received FDA 510(k) clearance on 1999-06-01 under 510(k) number K981353. The device is classified under product code MDA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVOGEL?

AVOGEL is a medical device that received FDA 510(k) clearance on 1999-06-01. The listed applicant is Avocet Polymer Technologies, Inc.. The 510(k) number is K981353.

When did AVOGEL receive FDA 510(k) clearance?

AVOGEL received FDA 510(k) clearance on 1999-06-01, under 510(k) number K981353.

Who is the listed applicant for AVOGEL?

The FDA 510(k) record lists Avocet Polymer Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AVOGEL?

The FDA product code for AVOGEL is MDA.

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Related Devices (Code: MDA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K112131NEODYNE DRESSINGNeodyne Biosciences, Inc.K111733CORELEADER SCAR-DIMMERCoreleader Biotech Co., Ltd.K083718BEAU RX SCAR CARE GELBeau RX Solutions, LLCK053481KELO-COTE SPRAYAdvanced Bio-Technologies, Inc.K041704NEWGEL AND NEWGEL PLUS ENewmedical Technology, Inc.K040307HANSON SCAR ADEHanson Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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