CUI PREMAXILLARY IMPLANT— 510(k) K903328

Name: FDA 510(k) clearance K903328
Creator: U.S. Food and Drug Administration
Published: 1990-09-10

Substantially Equivalent

Cui Corp.

FDA 510(k) clearance K903328 for CUI PREMAXILLARY IMPLANT, Substantially Equivalent on 1990-09-10. Applicant: Cui Corp.. Device class: 2.

Clearance details

Applicant: Cui Corp.
Product code: Code FZE
Device class: Class 2
Regulation: 21 CFR 878.3680
Advisory panel: General, Plastic Surgery
Date received: 1990-07-25
Decision date: 1990-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Cui Corp.

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K913140 — SILICONE GEL SHEETING1991-09-30
K904348 — CUI FEATHERED SILICONE MALAR1990-11-26
K904349 — CUI CURVILINEAR SILICONE CHIN1990-11-26
K904350 — CUI DORSAL COLUMELLA PROSTHESIS1990-11-26
K903327 — CUI ARTICULATED SILICONE CHIN1990-09-10

Adverse events under product code FZE

product code FZE

Injury: 138
Total: 138

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.