SILICONE GEL SHEETING— 510(k) K913140

Substantially Equivalent

Cui Corp.

FDA 510(k) clearance K913140 for SILICONE GEL SHEETING, Substantially Equivalent on 1991-09-30. Applicant: Cui Corp.. Device class: 1.

Clearance details

Applicant: Cui Corp.
Product code: Code MDA
Device class: Class 1
Regulation: 21 CFR 878.4025
Advisory panel: General, Plastic Surgery
Date received: 1991-07-16
Decision date: 1991-09-30
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.

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
K903328 — CUI PREMAXILLARY IMPLANT1990-09-10

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