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FDA 510(k)

AART NASAL IMPLANT

K-Number: K021418 · 2002-07-02

ApplicantAesthetic and Reconstructive Technologies, Inc.
Decision Date2002-07-02
Product CodeFZE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AART NASAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Aesthetic and Reconstructive Technologies, Inc.. It received FDA 510(k) clearance on 2002-07-02 under 510(k) number K021418. The device is classified under product code FZE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AART NASAL IMPLANT?

AART NASAL IMPLANT is a medical device that received FDA 510(k) clearance on 2002-07-02. The listed applicant is Aesthetic and Reconstructive Technologies, Inc.. The 510(k) number is K021418.

When did AART NASAL IMPLANT receive FDA 510(k) clearance?

AART NASAL IMPLANT received FDA 510(k) clearance on 2002-07-02, under 510(k) number K021418.

Who is the listed applicant for AART NASAL IMPLANT?

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

What is the FDA product code for AART NASAL IMPLANT?

The FDA product code for AART NASAL IMPLANT is FZE.

Related Clinical Trials

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.

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Other records listing Aesthetic and Reconstructive Technologies, Inc. as applicant

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.

K023678DIMISIL SCAR GELK022306AART SILICONE TUBINGK022511AART CALF IMPLANTK022223AART SILICONE SHEETINGK021839AART GLUTEAL IMPLANTK021820AART SILICONE CARVING BLOCK

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Related Devices (Code: FZE)

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.

K241253Medicon Epiplating SystemCmf Medicon Surgical, Inc.K161548Osseointegrated FixturesSouthern Implants (Pty), Ltd.K090803HANSON MEDICAL FACIAL IMPLANTSHanson Medical, Inc.K090630NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)Nobel Biocare ABK071018MONARCH NASAL IMPLANTHanson Medical, Inc.K041690MONARCH NASAL IMPLANTHanson Medical, Inc.

Official Source

View on FDA Database →

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

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