FDA 510(k)

CUI ANATOMICAL SILICONE MALAR

K-Number: K903329 · 1990-09-10

Decision Date1990-09-10

Product CodeLZK

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CUI ANATOMICAL SILICONE MALAR is the device name listed in this FDA 510(k) record. The listed applicant is Cui Corp.. It received FDA 510(k) clearance on 1990-09-10 under 510(k) number K903329. The device is classified under product code LZK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUI ANATOMICAL SILICONE MALAR?

CUI ANATOMICAL SILICONE MALAR is a medical device that received FDA 510(k) clearance on 1990-09-10. The listed applicant is Cui Corp.. The 510(k) number is K903329.

When did CUI ANATOMICAL SILICONE MALAR receive FDA 510(k) clearance?

CUI ANATOMICAL SILICONE MALAR received FDA 510(k) clearance on 1990-09-10, under 510(k) number K903329.

Who is the listed applicant for CUI ANATOMICAL SILICONE MALAR?

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 ANATOMICAL SILICONE MALAR?

The FDA product code for CUI ANATOMICAL SILICONE MALAR is LZK.

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Other records listing Cui Corp. as applicant

K913140SILICONE GEL SHEETING K904348CUI FEATHERED SILICONE MALAR K904349CUI CURVILINEAR SILICONE CHIN K904350CUI DORSAL COLUMELLA PROSTHESIS K903328CUI PREMAXILLARY IMPLANT K903327CUI ARTICULATED SILICONE CHIN

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Related Devices (Code: LZK)

K021419AART MALAR IMPLANTAesthetic and Reconstructive Technologies, Inc.K002886IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)Implantech Associates, Inc.K992240PILLAR MALAR IMPLANTPillar Surgical, Inc.K983756SURGIFORM ANATOMICAL MALARSurgical Technology Laboratories, Inc.K982763SEARE BIOMEDICAL MALAR IMPLANTSSeare Biomedical Corp.K981835SILIMED MALAR IMPLANTSilimed, LLC

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.