FDA 510(k)

CUI DORSAL COLUMELLA PROSTHESIS

K-Number: K904350 · 1990-11-26

Decision Date1990-11-26

Product CodeFZE

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CUI DORSAL COLUMELLA PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Cui Corp.. It received FDA 510(k) clearance on 1990-11-26 under 510(k) number K904350. 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 CUI DORSAL COLUMELLA PROSTHESIS?

CUI DORSAL COLUMELLA PROSTHESIS is a medical device that received FDA 510(k) clearance on 1990-11-26. The listed applicant is Cui Corp.. The 510(k) number is K904350.

When did CUI DORSAL COLUMELLA PROSTHESIS receive FDA 510(k) clearance?

CUI DORSAL COLUMELLA PROSTHESIS received FDA 510(k) clearance on 1990-11-26, under 510(k) number K904350.

Who is the listed applicant for CUI DORSAL COLUMELLA PROSTHESIS?

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

What is the FDA product code for CUI DORSAL COLUMELLA PROSTHESIS?

The FDA product code for CUI DORSAL COLUMELLA PROSTHESIS is FZE.

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Other records listing Cui Corp. as applicant

K913140SILICONE GEL SHEETING K904348CUI FEATHERED SILICONE MALAR K904349CUI CURVILINEAR SILICONE CHIN K903329CUI ANATOMICAL SILICONE MALAR K903328CUI PREMAXILLARY IMPLANT K903327CUI ARTICULATED SILICONE CHIN

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Related Devices (Code: FZE)

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 AB K071018MONARCH 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.