Cleared Traditional

TRAPEZOIDAL MALAR IMPLANT

K911513 · Implantech Associates, Inc. · General & Plastic Surgery
Jul 1991
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K911513 is an FDA 510(k) clearance for the TRAPEZOIDAL MALAR IMPLANT, a Implant, Malar (Class II — Special Controls, product code LZK), submitted by Implantech Associates, Inc. (Washington, US). The FDA issued a Cleared decision on July 1, 1991, 88 days after receiving the submission on April 4, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3550.

Submission Details

510(k) Number K911513 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 1991
Decision Date July 01, 1991
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code LZK — Implant, Malar
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3550

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