Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DURALASTIC ANATOMICAL NASAL IMPLANTS

K-Number: K973573 · 1997-11-13

ApplicantHanson Medical, Inc.
Decision Date1997-11-13
Product CodeFZE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DURALASTIC ANATOMICAL NASAL IMPLANTS 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 1997-11-13 under 510(k) number K973573. 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 DURALASTIC ANATOMICAL NASAL IMPLANTS?

DURALASTIC ANATOMICAL NASAL IMPLANTS is a medical device that received FDA 510(k) clearance on 1997-11-13. The listed applicant is Hanson Medical, Inc.. The 510(k) number is K973573.

When did DURALASTIC ANATOMICAL NASAL IMPLANTS receive FDA 510(k) clearance?

DURALASTIC ANATOMICAL NASAL IMPLANTS received FDA 510(k) clearance on 1997-11-13, under 510(k) number K973573.

Who is the listed applicant for DURALASTIC ANATOMICAL NASAL IMPLANTS?

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 DURALASTIC ANATOMICAL NASAL IMPLANTS?

The FDA product code for DURALASTIC ANATOMICAL NASAL IMPLANTS 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 IMPLANTK041690MONARCH NASAL IMPLANTK040307HANSON SCAR ADEK030808HANSON MEDICAL CALF IMPLANTK030809HANSON MEDICAL GLUTEAL IMPLANT

View all 13 devices →

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.

↑