Cleared Traditional

IMPLANTECH WM NASAL-LABIAL IMPLANT

K962261 · Implantech Associates, Inc. · General & Plastic Surgery
Aug 1996
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K962261 is an FDA 510(k) clearance for the IMPLANTECH WM NASAL-LABIAL 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 August 19, 1996, 68 days after receiving the submission on June 12, 1996. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3550.

Submission Details

510(k) Number K962261 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 1996
Decision Date August 19, 1996
Days to Decision 68 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

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

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