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FDA 510(k)

SEARE BIOMEDICAL NASAL IMPLANTS

K-Number: K982753 · 1998-09-30

ApplicantSeare Biomedical Corp.
Decision Date1998-09-30
Product CodeFZE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SEARE BIOMEDICAL NASAL IMPLANTS is the device name listed in this FDA 510(k) record. The listed applicant is Seare Biomedical Corp.. It received FDA 510(k) clearance on 1998-09-30 under 510(k) number K982753. 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 SEARE BIOMEDICAL NASAL IMPLANTS?

SEARE BIOMEDICAL NASAL IMPLANTS is a medical device that received FDA 510(k) clearance on 1998-09-30. The listed applicant is Seare Biomedical Corp.. The 510(k) number is K982753.

When did SEARE BIOMEDICAL NASAL IMPLANTS receive FDA 510(k) clearance?

SEARE BIOMEDICAL NASAL IMPLANTS received FDA 510(k) clearance on 1998-09-30, under 510(k) number K982753.

Who is the listed applicant for SEARE BIOMEDICAL NASAL IMPLANTS?

The FDA 510(k) record lists Seare Biomedical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEARE BIOMEDICAL NASAL IMPLANTS?

The FDA product code for SEARE BIOMEDICAL NASAL IMPLANTS is FZE.

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Other records listing Seare Biomedical Corp. 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.

K983792SEARE BIOMEDICAL SILICONE TISSUE EXPANDERK983630SEARE BIOMEDICAL SILICONE RODSK982752SEARE BIOMEDICAL CHIN IMPLANTSK982763SEARE BIOMEDICAL MALAR IMPLANTSK983043SEARE BIOMEDICAL SILICONE BLOCKK982762SEARE BIOMEDICAL PECTORALIS 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.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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