DURALASTIC ANATOMICAL MALAR IMPLANTS— 510(k) K971479

Name: FDA 510(k) clearance K971479
Creator: U.S. Food and Drug Administration
Published: 1997-07-18

Substantially Equivalent

Allied Biomedical Corp.

FDA 510(k) clearance K971479 for DURALASTIC ANATOMICAL MALAR IMPLANTS, Substantially Equivalent on 1997-07-18. Applicant: Allied Biomedical Corp.. Device class: 2.

Clearance details

Applicant: Allied Biomedical Corp.
Product code: Code LZK
Device class: Class 2
Regulation: 21 CFR 878.3550
Advisory panel: General, Plastic Surgery
Date received: 1997-04-23
Decision date: 1997-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paso Robles, CA, 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 Allied Biomedical Corp.

view all

K982051 — KELOCATE SHEETING1998-08-05
K971478 — DURALASTIC ANATOMICAL CHIN IMPLANTS1997-07-18
K971481 — DURALASTIC ANATOMICAL NASAL IMPLANTS1997-07-18
K971480 — DURALASTIC I AND DURALASTIC II1997-05-28
K955368 — DURALASTIC I1996-02-08

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