DURALASTIC ANATOMICAL NASAL IMPLANTS— 510(k) K971481

Name: FDA 510(k) clearance K971481
Creator: U.S. Food and Drug Administration
Published: 1997-07-18

Substantially Equivalent

Allied Biomedical Corp.

FDA 510(k) clearance K971481 for DURALASTIC ANATOMICAL NASAL IMPLANTS, Substantially Equivalent on 1997-07-18. Applicant: Allied Biomedical Corp.. Device class: 2.

Clearance details

Applicant: Allied Biomedical Corp.
Product code: Code FZE
Device class: Class 2
Regulation: 21 CFR 878.3680
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 ↗

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K971479 — DURALASTIC ANATOMICAL MALAR IMPLANTS1997-07-18
K971480 — DURALASTIC I AND DURALASTIC II1997-05-28
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Adverse events under product code FZE

product code FZE

Injury: 138
Total: 138

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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