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FDA 510(k)

MONARCH NASAL IMPLANT

K-Number: K041690 · 2005-02-11

ApplicantHanson Medical, Inc.
Decision Date2005-02-11
Product CodeFZE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MONARCH NASAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Hanson Medical, Inc.. It received FDA 510(k) clearance on 2005-02-11 under 510(k) number K041690. 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 MONARCH NASAL IMPLANT?

MONARCH NASAL IMPLANT is a medical device that received FDA 510(k) clearance on 2005-02-11. The listed applicant is Hanson Medical, Inc.. The 510(k) number is K041690.

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

MONARCH NASAL IMPLANT received FDA 510(k) clearance on 2005-02-11, under 510(k) number K041690.

Who is the listed applicant for MONARCH NASAL IMPLANT?

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

What is the FDA product code for MONARCH NASAL IMPLANT?

The FDA product code for MONARCH NASAL IMPLANT is FZE.

Related Clinical Trials

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Other records listing Hanson Medical, 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.

K090803HANSON MEDICAL FACIAL IMPLANTSK071018MONARCH NASAL IMPLANTK040307HANSON SCAR ADEK030809HANSON MEDICAL GLUTEAL IMPLANTK030808HANSON MEDICAL CALF IMPLANTK973729POWERFLEX PEC IMPLANT

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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.K021418AART NASAL IMPLANTAesthetic and Reconstructive Technologies, 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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