DURALASTIC SHEETING— 510(k) K935571

Substantially Equivalent

Applied Biomaterial Technologies

FDA 510(k) clearance K935571 for DURALASTIC SHEETING, Substantially Equivalent on 1995-01-31. Applicant: Applied Biomaterial Technologies.

Clearance details

Applicant: Applied Biomaterial Technologies
Product code: Code MIB
Advisory panel: Ear, Nose, Throat
Date received: 1993-11-18
Decision date: 1995-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Silverdale, WA, 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.