Cleared Traditional

PILLAR MALAR IMPLANT

K992240 · Pillar Surgical, Inc. · General & Plastic Surgery
Nov 1999
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K992240 is an FDA 510(k) clearance for the PILLAR MALAR IMPLANT, a Implant, Malar (Class II — Special Controls, product code LZK), submitted by Pillar Surgical, Inc. (La Jolla, US). The FDA issued a Cleared decision on November 22, 1999, 143 days after receiving the submission on July 2, 1999. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3550.

Submission Details

510(k) Number K992240 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 1999
Decision Date November 22, 1999
Days to Decision 143 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

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

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