DURALASTIC I— 510(k) K955368

Substantially Equivalent

Allied Biomedical Corp.

FDA 510(k) clearance K955368 for DURALASTIC I, Substantially Equivalent on 1996-02-08. Applicant: Allied Biomedical Corp..

Clearance details

Applicant: Allied Biomedical Corp.
Product code: Code MIB
Advisory panel: Ear, Nose, Throat
Date received: 1995-11-22
Decision date: 1996-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goose Creek, SC, US

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Adverse events under product code MIB

product code MIB

Injury: 146
Total: 146

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.