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FDA 510(k)

BYRON DORSAL COLUMELLA IMPLANT

K-Number: K863399 · 1986-09-17

ApplicantByron Medical
Decision Date1986-09-17
Product CodeFZE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BYRON DORSAL COLUMELLA IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Byron Medical. It received FDA 510(k) clearance on 1986-09-17 under 510(k) number K863399. 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 BYRON DORSAL COLUMELLA IMPLANT?

BYRON DORSAL COLUMELLA IMPLANT is a medical device that received FDA 510(k) clearance on 1986-09-17. The listed applicant is Byron Medical. The 510(k) number is K863399.

When did BYRON DORSAL COLUMELLA IMPLANT receive FDA 510(k) clearance?

BYRON DORSAL COLUMELLA IMPLANT received FDA 510(k) clearance on 1986-09-17, under 510(k) number K863399.

Who is the listed applicant for BYRON DORSAL COLUMELLA IMPLANT?

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

What is the FDA product code for BYRON DORSAL COLUMELLA IMPLANT?

The FDA product code for BYRON DORSAL COLUMELLA IMPLANT is FZE.

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Other records listing Byron Medical 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.

K040149PSI-TEC PERISTALTIC INFILTRATION PUMPK001803ACCELERATOR RECIPROCATING CANNULAK981215PSI-TEC LIPOSUCTION ASPIRATORK981172LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLESK980738PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATIONK980392PSI-TEC ASPIRATOR

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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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