CUI FEATHERED SILICONE MALAR— 510(k) K904348

Substantially Equivalent

Cui Corp.

FDA 510(k) clearance K904348 for CUI FEATHERED SILICONE MALAR, Substantially Equivalent on 1990-11-26. Applicant: Cui Corp.. Device class: 2.

Clearance details

Applicant: Cui Corp.
Product code: Code LZK
Device class: Class 2
Regulation: 21 CFR 878.3550
Advisory panel: General, Plastic Surgery
Date received: 1990-09-24
Decision date: 1990-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LZK

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K992240 — PILLAR MALAR IMPLANT1999-11-22
K983756 — SURGIFORM ANATOMICAL MALAR1998-11-20
K982763 — SEARE BIOMEDICAL MALAR IMPLANTS1998-09-30

More clearances from Cui Corp.

K913140 — SILICONE GEL SHEETING1991-09-30
K904349 — CUI CURVILINEAR SILICONE CHIN1990-11-26
K904350 — CUI DORSAL COLUMELLA PROSTHESIS1990-11-26
K903327 — CUI ARTICULATED SILICONE CHIN1990-09-10
K903328 — CUI PREMAXILLARY IMPLANT1990-09-10

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