BINDER SUBMALAR FACIAL IMPLANT— 510(k) K894493

Name: FDA 510(k) clearance K894493
Creator: U.S. Food and Drug Administration
Published: 1989-10-27

Substantially Equivalent

Implantech Associates, Inc.

FDA 510(k) clearance K894493 for BINDER SUBMALAR FACIAL IMPLANT, Substantially Equivalent on 1989-10-27. Applicant: Implantech Associates, Inc.. Device class: 2.

Clearance details

Applicant: Implantech Associates, Inc.
Product code: Code LZK
Device class: Class 2
Regulation: 21 CFR 878.3550
Advisory panel: General, Plastic Surgery
Date received: 1989-07-19
Decision date: 1989-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LZK

view all

K021419 — AART MALAR IMPLANT2002-07-02
K002886 — IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)2000-11-24
K992240 — PILLAR MALAR IMPLANT1999-11-22
K983756 — SURGIFORM ANATOMICAL MALAR1998-11-20
K982763 — SEARE BIOMEDICAL MALAR IMPLANTS1998-09-30

More clearances from Implantech Associates, Inc.

view all

K200610 — Customized Contour Implant2020-12-23
K191130 — Customized Contour Implant2019-08-23
K172389 — ePTFE-Coated Auricular Implant2018-07-18
K141027 — 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP2014-07-10
K071470 — IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX2007-08-31

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