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FDA 510(k)

SILIMED NASAL L SHAPED IMPLANT

K-Number: K981833 · 1998-06-26

ApplicantSilimed, LLC
Decision Date1998-06-26
Product CodeFZE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SILIMED NASAL L SHAPED IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Silimed, LLC. It received FDA 510(k) clearance on 1998-06-26 under 510(k) number K981833. 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 SILIMED NASAL L SHAPED IMPLANT?

SILIMED NASAL L SHAPED IMPLANT is a medical device that received FDA 510(k) clearance on 1998-06-26. The listed applicant is Silimed, LLC. The 510(k) number is K981833.

When did SILIMED NASAL L SHAPED IMPLANT receive FDA 510(k) clearance?

SILIMED NASAL L SHAPED IMPLANT received FDA 510(k) clearance on 1998-06-26, under 510(k) number K981833.

Who is the listed applicant for SILIMED NASAL L SHAPED IMPLANT?

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

What is the FDA product code for SILIMED NASAL L SHAPED IMPLANT?

The FDA product code for SILIMED NASAL L SHAPED IMPLANT is FZE.

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Other records listing Silimed, LLC 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.

K981852SILIMED TISSUE EXPANDERK974479SILIMED VAGINAL STENTK981835SILIMED MALAR IMPLANTK981850SILIMED CHIN IMPLANTSK981851SILIMED SILICONE CARVING BLOCKK980221SILIMED NASAL RETAINER

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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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